Z-0907-2018Class II

Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of...

Name: Z-0907-2018 Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of...
Creator: Synthes (USA) Products LLC
Published: 2017-07-26
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2017-07-26 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery on 2017-07-26. FDA classified it as Class II and gives the reason as "Possible lack of product sterility due to potential gaps/channeling in the seal of the package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0907-2018
Classification: Class II
Status: Terminated
Initiated: 2017-07-26
Posted: 2018-03-05
Terminated: 2018-09-10
Recalling firm: Synthes (USA) Products LLC
Product: Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Product code: HTO Reamer
Reason for recall: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: [email protected] Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you DO have any of the identified devices, and are returning the product for replacement, please take the following steps: Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section (page 4 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Return the Verification Section (page 4 of this letter) with the product to: o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: [email protected] Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea
Quantity in commerce: 6
Distribution: Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
Product codes and lots: Distributed 21-Apr-2017 to 12-May-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H310383 4/20/2017 2022-02-28 H322619 4/20/2017 2022-02-28 H327938 4/20/2017 2022-02-28

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0907-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0901-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0902-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0903-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0904-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0905-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0906-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05
Z-0907-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-14	2018-03-05

Product code HTO

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)