Z-2930-2020Class II

StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO -

Name: Z-2930-2020 StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO -
Creator: Stimwave Technologies Inc
Published: 2020-07-15
License: https://open.fda.gov/license/

Curonix LLC / initiated 2020-07-15 / Open, Classified / root cause: labeling and UDI

FDA source

Stimwave Technologies Inc began a recall of StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to... on 2020-07-15. FDA classified it as Class II and gives the reason as "The product contains a non-functional component not referenced in product labeling". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2930-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-07-15
Posted: 2020-09-02
Recalling firm: Curonix LLC
Product: StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US and 2. FR4A-TR-BO - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.
Product code: GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Reason for recall: The product contains a non-functional component not referenced in product labeling.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Field Safety Correction/Advisory Notices were sent to Distributors, Regional Sales Directors, and Territory Managers via email on 07/15/2020, describing the issue, recall instructions and their responsibilities. Prior to this communication, these parties received training on 07/13/2020 on the field action activities identifying the issue, instructions, and their responsibilities as explained in the letter. A physician letter was issued on 08/06/2020 to inform physicians of the recall.
Quantity in commerce: 1424 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KY, KS, LA, MD, MO, MI, MN, MA, MS, NC, NM, ND, NV, NY, NE, NJ, OK, OH, OR, PR, PA, RI, SC, TN, TX, UT, VA, WA, WI and the countries of The Netherlands, Belgium, Slovakia, Switzerland, Germany, United Kingdom, Argentina, Italy, Spain, South Africa, Iran, Israel, and Czech Republic.
Product codes and lots: 1. FR4A-TRL-BO-US, Serial Numbers: 211666-1, 211666-10, 211666-11, 211666-12, 211666-13, 211666-14, 211666-15, 211666-16, 211666-17, 211666-18, 211666-19, 211666-2, 211666-20, 211666-21, 211666-22, 211666-23, 211666-24, 211666-25, 211666-26, 211666-27, 211666-28, 211666-29, 211666-3, 211666-30, 211666-31, 211666-32, 211666-33, 211666-34, 211666-35, 211666-36, 211666-37, 211666-38, 211666-39, 211666-4, 211666-40, 211666-41, 211666-42, 211666-43, 211666-44, 211666-45, 211666-46, 211666-47, 211666-48, 211666-49, 211666-5, 211666-50, 211666-51, 211666-52, 211666-53, 211666-54, 211666-55, 211666-56, 211666-57, 211666-58, 211666-59, 211666-6, 211666-60, 211666-61, 211666-62, 211666-63, 211666-64, 211666-65, 211666-66, 211666-67, 211666-68, 211666-69, 211666-7, 211666-70, 211666-71, 211666-72, 211666-73, 211666-74, 211666-75, 211666-76, 211666-77, 211666-78, 211666-79, 211666-8, 211666-80, 211666-81, 211666-82, 211666-83, 211666-84, 211666-85, 211666-86, 211666-87, 211666-88, 211666-89, 211666-9, 211666-90, 211666-91, 211666-92, 211666-93, 211666-94, 211666-95, 211666-96, 211666-97, 211666-98 211614-1, 211614-10, 211614-11, 211614-12, 211614-13, 211614-14, 211614-15, 211614-16, 211614-17, 211614-18, 211614-19, 211614-2, 211614-20, 211614-21, 211614-22, 211614-23, 211614-24, 211614-25, 211614-26, 211614-27, 211614-28, 211614-29, 211614-3, 211614-30, 211614-31, 211614-32, 211614-33, 211614-34, 211614-35, 211614-36, 211614-37, 211614-38, 211614-39, 211614-4, 211614-40, 211614-41, 211614-42, 211614-43, 211614-44, 211614-45, 211614-46, 211614-47, 211614-48, 211614-49, 211614-5, 211614-50, 211614-51, 211614-52, 211614-53, 211614-54, 211614-55, 211614-56, 211614-57, 211614-58, 211614-59, 211614-6, 211614-60, 211614-61, 211614-62, 211614-63, 211614-64, 211614-65, 211614-66, 211614-67, 211614-68, 211614-69, 211614-7, 211614-70, 211614-71, 211614-72, 211614-73, 211614-74, 211614-75, 211614-76, 211614-77, 211614-78, 211614-79, 211614-8, 211614-80, 211614-81, 211614-82, 211614-83, 211614-84, 211614-85, 211614-86, 211614-87, 211614-88, 211614-89, 211614-9, 211614-90, 211614-91, 211614-92, 211614-93, 211614-94, 211614-95 , 211579-1, 211579-10, 211579-11, 211579-12, 211579-13, 211579-14, 211579-15, 211579-16, 211579-17, 211579-18, 211579-19, 211579-2, 211579-20, 211579-21, 211579-22, 211579-23, 211579-24, 211579-25, 211579-26, 211579-30, 211579-31, 211579-32, 211579-33, 211579-34, 211579-35, 211579-36, 211579-37, 211579-38, 211579-4, 211579-40, 211579-41, 211579-42, 211579-43, 211579-45, 211579-46, 211579-49, 211579-5, 211579-50, 211579-51, 211579-52, 211579-53, 211579-54, 211579-55, 211579-56, 211579-57, 211579-58, 211579-59, 211579-6, 211579-61, 211579-62, 211579-63, 211579-64, 211579-65, 211579-66, 211579-67, 211579-68, 211579-69, 211579-7, 211579-70, 211579-71, 211579-72, 211579-73, 211579-74, 211579-75, 211579-76, 211579-77, 211579-78, 211579-79, 211579-8, 211579-80, 211579-81, 211579-82, 211579-83, 211579-84, 211579-85, 211579-86, 211579-87, 211579-88, 211579-89, 211579-9, 211579-90, 211579-91, 211579-95, 211579-97, 211579-98 211578-1, 211578-10, 211578-11, 211578-12, 211578-13, 211578-14, 211578-15, 211578-16, 211578-17, 211578-18, 211578-19, 211578-2, 211578-20, 211578-21, 211578-22, 211578-23, 211578-24, 211578-25, 211578-26, 211578-27, 211578-28, 211578-29, 211578-3, 211578-30, 211578-31, 211578-32, 211578-33, 211578-34, 211578-35, 211578-36, 211578-37, 211578-38, 211578-39, 211578-4, 211578-40, 211578-41, 211578-42, 211578-43, 211578-44, 211578-45, 211578-46, 211578-47, 211578-48, 211578-49, 211578-5, 211578-50, 211578-51, 211578-52, 211578-53, 211578-54, 211578-55, 211578-56, 211578-57, 211578-58, 211578-59, 211578-6, 211578-60, 211578-61, 211578-62, 211578-63, 211578-64, 211578-65, 211578-66, 211578-67, 211578-68, 211578-69, 211578-7, 211578-70, 211578-71, 211578-72, 211578-73, 211578-74, 211578-75, 211578-76, 211578-77, 211578-78, 211578-79, 211578-8, 211578-80, 211578-81, 211578-82, 211578-83, 211578-84, 211578-85, 211578-86, 211578-87, 211578-88, 211578-89, 211578-9, 211578-90, 211578-91, 211578-92 2B10866-1, 2B10866-2, 2B10866-3, 2B10866-4, 2B10866-5, 2B10866-6, 2B10866-7, 2B10866-8, 2B10866-9, 2B10866-10, 2B10866-11, 2B10866-12, 2B10866-13, 2B10866-14, 2B10866-15, 2B10866-16, 2B10866-17, 2B10866-18, 2B10866-19, 2B10866-20, 2B10866-21, 2B10866-22, 2B10866-23, 2B10866-24, 2B10866-25, 2B10866-26, 2B10866-27, 2B10866-28, 2B10866-29, 2B10866-30, 2B10866-31, 2B10866-32, 2B10866-33, 2B10866-34, 2B10866-35, 2B10866-36, 2B10866-37, 2B10866-38, 2B10866-39, 2B10866-40, 2B10866-41, 2B10866-42, 2B10866-43, 2B10866-44, 2B10866-45, 2B10866-46, 2B10866-47, 2B10866-48, 2B10866-49, 2B10866-50, 2B10866-51, 2B10866-52, 2B10866-53, 2B10866-54, 2B10866-55, 2B10866-56, 2B10866-57, 2B10866-58, 2B10866-59, 2B10866-60, 2B10866-61, 2B10866-62, 2B10866-63, 2B10866-64, 2B10866-65, 2B10866-66, 2B10866-67, 2B10866-68, 2B10866-69, 2B10866-70, 2B10866-71, 2B10866-72, 2B10866-73, 2B10866-74, 2B10866-75, 2B10866-76, 2B10866-77, 2B10866-78, 2B10866-79, 2B10866-80, 2B10866-81, 2B10866-82, 2B10866-83, 2B10866-84, 2B10866-85, 2B10866-86, 2B10866-87, 2B10866-88, 2B10866-89, 2B10866-90, 2B10866-91, 2B10866-92, 2B10866-93, 2B10866-94, 2B10866-95, 2B10866-96, 2B10866-97, 2B10866-98, 2B10866-99, 2B10866-100, 2B10866-101, 2B10866-102, 2B10866-103, 2B10866-104, 2B10866-105, 2B10866-106, 2B10866-107, 2B10866-108, 2B10866-109, 2B10866-110, 2B10866-111, 2B10866-112, 2B10866-113, 2B10866-114, 2B10866-115, 2B10866-116, 2B10866-117, 2B10866-118, 2B10866-119, 2B10866-120 210860-1, 210860-10, 210860-11, 210860-12, 210860-13, 210860-14, 210860-15, 210860-16, 210860-17, 210860-18, 210860-19, 210860-2, 210860-20, 210860-21, 210860-22, 210860-23, 210860-24, 210860-25, 210860-26, 210860-27, 210860-28, 210860-29, 210860-3, 210860-30, 210860-31, 210860-32, 210860-33, 210860-34, 210860-35, 210860-36, 210860-37, 210860-38, 210860-39, 210860-4, 210860-40, 210860-41, 210860-42, 210860-43, 210860-44, 210860-45, 210860-46, 210860-47, 210860-48, 210860-49, 210860-5, 210860-50, 210860-51, 210860-52, 210860-53, 210860-54, 210860-55, 210860-56, 210860-57, 210860-58, 210860-59, 210860-6, 210860-60, 210860-61, 210860-62, 210860-63, 210860-64, 210860-65, 210860-66, 210860-67, 210860-68, 210860-69, 210860-7, 210860-70, 210860-71, 210860-72, 210860-73, 210860-74, 210860-75, 210860-76, 210860-77, 210860-78, 210860-79, 210860-8, 210860-80, 210860-81, 210860-82, 210860-83, 210860-84, 210860-9 210432-1, 210432-10, 210432-11, 210432-12, 210432-13, 210432-14, 210432-15, 210432-16, 210432-17, 210432-18, 210432-19, 210432-2, 210432-20, 210432-21, 210432-22, 210432-23, 210432-24, 210432-25, 210432-26, 210432-27, 210432-28, 210432-29, 210432-3, 210432-30, 210432-31, 210432-32, 210432-33, 210432-34, 210432-35, 210432-36, 210432-37, 210432-38, 210432-39, 210432-4, 210432-40, 210432-41, 210432-42, 210432-43, 210432-44, 210432-45, 210432-46, 210432-47, 210432-48, 210432-49, 210432-5, 210432-50, 210432-51, 210432-52, 210432-53, 210432-54, 210432-55, 210432-56, 210432-57, 210432-58, 210432-59, 210432-6, 210432-60, 210432-61, 210432-62, 210432-63, 210432-64, 210432-65, 210432-66, 210432-67, 210432-68, 210432-69, 210432-7, 210432-70, 210432-71, 210432-72, 210432-73, 210432-74, 210432-75, 210432-76, 210432-77, 210432-78, 210432-79, 210432-8, 210432-80, 210432-81, 210432-82, 210432-9 210431-1, 210431-10, 210431-13, 210431-15, 210431-2, 210431-21, 210431-22, 210431-3, 210431-4, 210431-53, 210431-61, 210431-68, 210431-74 210430-1, 210430-10, 210430-11, 210430-12, 210430-13, 210430-14, 210430-15, 210430-16, 210430-17, 210430-18, 210430-19, 210430-2, 210430-20, 210430-21, 210430-22, 210430-23, 210430-24, 210430-25, 210430-26, 210430-27, 210430-28, 210430-29, 210430-3, 210430-30, 210430-31, 210430-32, 210430-33, 210430-34, 210430-35, 210430-36, 210430-37, 210430-38, 210430-39, 210430-4, 210430-40, 210430-41, 210430-42, 210430-43, 210430-44, 210430-45, 210430-46, 210430-47, 210430-48, 210430-49, 210430-5, 210430-50, 210430-51, 210430-52, 210430-53, 210430-54, 210430-55, 210430-56, 210430-57, 210430-58, 210430-59, 210430-6, 210430-60, 210430-61, 210430-62, 210430-63, 210430-64, 210430-65, 210430-66, 210430-67, 210430-68, 210430-69, 210430-7, 210430-70, 210430-71, 210430-72, 210430-73, 210430-74, 210430-75, 210430-76, 210430-77, 210430-78, 210430-79, 210430-8, 210430-80, 210430-81, 210430-82, 210430-83, 210430-84, 210430-85, 210430-86, 210430-87, 210430-88, 210430-89, 210430-9, 210430-90, 210430-91, 210430-92, 210430-93, 210430-94, 210430-95 210429-1, 210429-10, 210429-11, 210429-12, 210429-13, 210429-14, 210429-15, 210429-16, 210429-17, 210429-18, 210429-19, 210429-2, 210429-20, 210429-21, 210429-22, 210429-23, 210429-24, 210429-25, 210429-26, 210429-27, 210429-28, 210429-29, 210429-3, 210429-30, 210429-31, 210429-32, 210429-33, 210429-34, 210429-35, 210429-36, 210429-37, 210429-38, 210429-39, 210429-4, 210429-40, 210429-41, 210429-42, 210429-43, 210429-44, 210429-45, 210429-46, 210429-47, 210429-48, 210429-49, 210429-5, 210429-50, 210429-51, 210429-52, 210429-53, 210429-54, 210429-55, 210429-56, 210429-57, 210429-58, 210429-59, 210429-6, 210429-60, 210429-61, 210429-62, 210429-63, 210429-64, 210429-65, 210429-66, 210429-67, 210429-68, 210429-69, 210429-7, 210429-70, 210429-71, 210429-72, 210429-73, 210429-74, 210429-75, 210429-76, 210429-77, 210429-78, 210429-79, 210429-8, 210429-80, 210429-81, 210429-82, 210429-83, 210429-84, 210429-85, 210429-86, 210429-87, 210429-89, 210429-9, 210429-90, 210429-91, 210429-92, 210429-93, 210429-94 210427-10, 210427-11, 210427-12, 210427-13, 210427-14, 210427-15, 210427-16, 210427-17, 210427-18, 210427-19, 210427-20, 210427-21, 210427-22, 210427-23, 210427-24, 210427-25, 210427-26, 210427-27, 210427-28, 210427-29, 210427-30, 210427-31, 210427-32, 210427-33, 210427-34, 210427-35, 210427-36, 210427-37, 210427-38, 210427-39, 210427-40, 210427-41, 210427-42, 210427-43, 210427-44, 210427-6, 210427-7, 210427-8, 210427-9 209711-1, 209711-10, 209711-11, 209711-12, 209711-13, 209711-14, 209711-15, 209711-16, 209711-17, 209711-18, 209711-19, 209711-2, 209711-20, 209711-21, 209711-22, 209711-23, 209711-24, 209711-25, 209711-26, 209711-27, 209711-3, 209711-4, 209711-5, 209711-6, 209711-7, 209711-8, 209711-9 209704-1, 209704-14, 209704-5, 209704-6, 209704-7 209690-1, 209690-3, 209690-5 209558-19, 209558-21, 209558-26, 209558-29, 209558-3 209557-1, 209557-10, 209557-11, 209557-12, 209557-13, 209557-14, 209557-15, 209557-16, 209557-17, 209557-18, 209557-19, 209557-2, 209557-20, 209557-21, 209557-22, 209557-23, 209557-3, 209557-35, 209557-4, 209557-47, 209557-5, 209557-6, 209557-7, 209557-8, 209557-9 201249-1, 201249-2, 201249-3, 201249-4, 201249-5 201248-11, 201248-12, 201248-13, 201248-14, 201248-15, 201248-16, 201248-17, 201248-18, 201248-19, 201248-20, 201248-21, 201248-22, 201248-23, 201248-24, 201248-25, 201248-26, 201248-27, 201248-28, 201248-29, 201248-30, 201248-31, 201248-32 201247-1, 201247-10, 201247-11, 201247-12, 201247-13, 201247-14, 201247-15, 201247-16, 201247-17, 201247-18, 201247-19, 201247-2, 201247-20, 201247-21, 201247-22, 201247-23, 201247-24, 201247-25, 201247-26, 201247-27, 201247-28, 201247-29, 201247-3, 201247-30, 201247-31, 201247-32, 201247-33, 201247-34, 201247-35, 201247-36, 201247-37, 201247-38, 201247-39, 201247-4, 201247-40, 201247-41, 201247-42, 201247-43, 201247-44, 201247-45, 201247-46, 201247-47, 201247-48, 201247-49, 201247-5, 201247-50, 201247-6, 201247-7, 201247-8, 201247-9 201246-1, 201246-10, 201246-11, 201246-12, 201246-13, 201246-14, 201246-15, 201246-16, 201246-17, 201246-18, 201246-19, 201246-2, 201246-20, 201246-21, 201246-22, 201246-23, 201246-24, 201246-25, 201246-26, 201246-27, 201246-28, 201246-29, 201246-3, 201246-30, 201246-31, 201246-32, 201246-33, 201246-34, 201246-35, 201246-36, 201246-37, 201246-38, 201246-39, 201246-4, 201246-40, 201246-41, 201246-42, 201246-43, 201246-44, 201246-45, 201246-46, 201246-5, 201246-6, 201246-7, 201246-8, 201246-9, Expansion New Serial Numbers: 211579-27, 211579-3, 211579-39, 211579-44, 211579-47, 211579-48, 211579-60, 211579-92, 211579-93, 211579-94, 211579-96, 2B10867-1, 2B10867-101, 2B10867-102, 2B10867-103, 2B10867-105, 2B10867-107, 2B10867-108, 2B10867-11, 2B10867-110, 2B10867-14, 2B10867-15, 2B10867-16, 2B10867-17, 2B10867-18, 2B10867-19, 2B10867-2, 2B10867-20, 2B10867-21, 2B10867-22, 2B10867-23, 2B10867-25, 2B10867-26, 2B10867-27, 2B10867-28, 2B10867-29, 2B10867-3, 2B10867-31, 2B10867-32, 2B10867-33, 2B10867-34, 2B10867-36, 2B10867-37, 2B10867-38, 2B10867-40, 2B10867-41, 2B10867-42, 2B10867-44, 2B10867-45, 2B10867-48, 2B10867-49, 2B10867-5, 2B10867-50, 2B10867-52, 2B10867-53, 2B10867-54, 2B10867-57, 2B10867-58, 2B10867-6, 2B10867-62, 2B10867-64, 2B10867-65, 2B10867-70, 2B10867-71, 2B10867-72, 2B10867-73, 2B10867-74, 2B10867-75, 2B10867-76, 2B10867-77, 2B10867-79, 2B10867-80, 2B10867-81, 2B10867-82, 2B10867-83, 2B10867-84, 2B10867-86, 2B10867-87, 2B10867-88, 2B10867-89, 2B10867-9, 2B10867-91, 2B10867-92, 2B10867-93, 2B10867-97, 2B10867-98, 2B10867-99, 2B11089-1, 2B11089-10, 2B11089-100, 2B11089-101, 2B11089-102, 2B11089-103, 2B11089-105, 2B11089-108, 2B11089-109, 2B11089-11, 2B11089-110, 2B11089-111, 2B11089-112, 2B11089-113, 2B11089-114, 2B11089-115, 2B11089-116, 2B11089-117, 2B11089-118, 2B11089-119, 2B11089-14, 2B11089-15, 2B11089-16, 2B11089-18, 2B11089-19, 2B11089-2, 2B11089-21, 2B11089-24, 2B11089-25, 2B11089-26, 2B11089-27, 2B11089-29, 2B11089-3, 2B11089-30, 2B11089-32, 2B11089-33, 2B11089-34, 2B11089-35, 2B11089-36, 2B11089-37, 2B11089-38, 2B11089-39, 2B11089-4, 2B11089-40, 2B11089-41, 2B11089-42, 2B11089-43, 2B11089-44, 2B11089-45, 2B11089-46, 2B11089-48, 2B11089-49, 2B11089-5, 2B11089-50, 2B11089-51, 2B11089-52, 2B11089-53, 2B11089-54, 2B11089-55, 2B11089-57, 2B11089-58, 2B11089-59, 2B11089-6, 2B11089-60, 2B11089-62, 2B11089-64, 2B11089-65, 2B11089-66, 2B11089-67, 2B11089-68, 2B11089-69, 2B11089-7, 2B11089-70, 2B11089-71, 2B11089-73, 2B11089-74, 2B11089-75, 2B11089-76, 2B11089-79, 2B11089-8, 2B11089-80, 2B11089-89, 2B11089-92, 2B11089-93, 2B11089-94, 2B11089-95, 2B11089-96, 2B11089-97, 2B11089-98, 2B11089-99, 2B11635-1, 2B11635-10, 2B11635-11, 2B11635-12, 2B11635-14, 2B11635-15, 2B11635-17, 2B11635-18, 2B11635-19, 2B11635-2, 2B11635-22, 2B11635-24, 2B11635-25, 2B11635-27, 2B11635-28, 2B11635-29, 2B11635-3, 2B11635-30, 2B11635-31, 2B11635-32, 2B11635-34, 2B11635-36, 2B11635-38, 2B11635-39, 2B11635-4, 2B11635-40, 2B11635-41, 2B11635-49, 2B11635-5, 2B11635-50, 2B11635-52, 2B11635-53, 2B11635-54, 2B11635-55, 2B11635-56, 2B11635-57, 2B11635-58, 2B11635-59, 2B11635-60, 2B11635-67, 2B11663-10, 2B11663-11, 2B11663-12, 2B11663-13, 2B11663-14, 2B11663-15, 2B11663-21, 2B11663-24, 2B11663-25, 2B11663-26, 2B11663-27, 2B11663-28, 2B11663-29, 2B11663-3, 2B11663-30, 2B11663-31, 2B11663-32, 2B11663-35, 2B11663-36, 2B11663-37, 2B11663-38, 2B11663-39, 2B11663-4, 2B11663-41, 2B11663-42, 2B11663-43, 2B11663-44, 2B11663-46, 2B11663-47, 2B11663-48, 2B11663-49, 2B11663-5, 2B11663-50, 2B11663-51, 2B11663-56, 2B11663-57, 2B11663-58, 2B11663-59, 2B11663-6, 2B11663-60, 2B11663-61, 2B11663-62, 2B11663-63, 2B11663-64, 2B11663-65, 2B11663-66, 2B11663-67, 2B11663-69, 2B11663-7, 2B11663-71, 2B11663-73, 2B11663-74, 2B11663-75, 2B11663-76, 2B11663-78, 2B11663-8, 2B11663-82, 2B11663-88, 2B11663-90, 2B11667-1, 2B11667-11, 2B11667-12, 2B11667-13, 2B11667-14, 2B11667-15, 2B11667-16, 2B11667-17, 2B11667-18, 2B11667-19, 2B11667-2, 2B11667-25, 2B11667-26, 2B11667-27, 2B11667-28, 2B11667-3, 2B11667-31, 2B11667-33, 2B11667-34, 2B11667-35, 2B11667-36, 2B11667-37, 2B11667-38, 2B11667-39, 2B11667-40, 2B11667-43, 2B11667-44, 2B11667-45, 2B11667-46, 2B11667-48, 2B11667-49, 2B11667-5, 2B11667-50, 2B11667-51, 2B11667-52, 2B11667-54, 2B11667-56, 2B11667-58, 2B11667-59, 2B11667-60, 2B11667-61, 2B11667-64, 2B11667-65, 2B11667-66, 2B11667-67, 2B11667-69, 2B11667-7, 2B11667-70, 2B11667-71, 2B11667-72, 2B11667-73, 2B11667-74, 2B11667-75, 2B11667-76, 2B11667-77, 2B11667-79, 2B11667-82, 2B11667-86, 2B11667-88, 2B11667-89, 2B11667-90, 2B11667-91, 2B11667-92; 2. FR4A-TRL-B0, Serial Numbers: 2B10867-39

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2930-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2928-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02
Z-2929-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02
Z-2930-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02
Z-2931-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02
Z-2932-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02
Z-2933-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-09-09	2020-09-02

Product code GZF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)