Z-2458-2023Class II

PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f)...

Name: Z-2458-2023 PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f)...
Creator: Medicrea International
Published: 2023-07-12
License: https://open.fda.gov/license/

Medicrea International / initiated 2023-07-12 / Open, Classified / root cause: packaging

FDA source

Medicrea International began a recall of PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j)... on 2023-07-12. FDA classified it as Class II and gives the reason as "There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2458-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-12
Posted: 2023-08-24
Recalling firm: Medicrea International
Product: PASS LP, REF numbers: a) B02315535Z, b) B02315540Z, c) B02315545Z, d) B02315550Z, e) B02316535Z, f) B02316540Z, g) B02316545Z, h) B02316550Z, i) B02317540Z, j) B02317545Z, k) B02317550Z; intervertebral fusion device - cervical
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Beginning 12 July 2023, In the U.S. Medtronic disseminated an URGENT: MEDICAL PRODUCT RECALL to its consignees via UPS 2-Day delivery. The notice explained the problem, risk, and requested the following: Medtronic requests that you immediately take the following actions: Identify and quarantine any unused impacted product(s). Return all unused and non-expired product(s) in your inventory to Medtronic following the instructions in the enclosed Customer Confirmation Form. Your Medtronic Sales Representative can assist in returning any affected consignment and loaner inventory, if applicable. Complete the Customer Confirmation Form enclosed with this letter (even if you have no product to return), acknowledging that you have received this information. This notice should be distributed to all others in your organization who should be aware, or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.
Quantity in commerce: 963 units
Distribution: US nationwide
Product codes and lots: a) B02315535Z, GTIN 03613720185086, Lot Numbers: 21J0184; b) B02315540Z, GTIN 03613720185116, Lot Numbers: 18E0322, 18F1011, 18G0704, 18I0780, 18K0862, 19B0091, 19B0731, 19D0267, 19F0460, 19J0742, 20A0966, 20F0008, 20I0200, 20I0833, 22I0616; c) B02315545Z, GTIN 03613720185147, Lot Numbers: 18H0617, 18I0682, 18J0215, 18K0863, 19K0545, 20H0147; d) B02315550Z, GTIN 03613720185178, Lot Numbers: 19E0306, 20F0009; e) B02316535Z, GTIN 03613720185321, Lot Numbers: 21J0185, 21J0899; f) B02316540Z, GTIN 03613720185352, Lot Numbers: 18E0478, 18H0672, 18K0278, 18K0864, 19A0645, 19B0318, 19B0777, 19C0417, 19C0739, 19E0082, 19I0573, 20A0596, 20B0687, 20H0148, 20J0414, 21A0107, 22A0297, 22I0339; g) B02316545Z, GTIN 03613720185383, Lot Numbers: 18D1035, 18E0508, 18F0534, 18G0170, 18G0591, 18H0588, 18J0054, 18K0279, 18K0865, 19A0066, 19B0093, 19B0912, 19C0138, 19D0177, 19E0084, 19G0188, 19J0227, 19J0228, 19K0764, 19L0360, 19L0580, 20B0688, 20H0151, 20J0415, 20L0238, 21A0109, 21A0642, 21D0174, 21F0505, 21L0394, 22A0047, 22L0091; h) B02316550Z, GTIN 03613720185413, Lot Numbers: 21A0506, 21C0501; i) B02317540Z, GTIN 03613720185598, Lot Numbers: 21A0110, 21A0508, 21A0524, 22B0782; j) B02317545Z, GTIN 03613720185628, Lot Numbers: 20E0097, 21A0076, 21B0498; k) B02317550Z, GTIN 03613720185659, Lot Numbers: 20C0294, 20H0508, 20J0283, 22B0366

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2458-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2452-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2453-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2454-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2455-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2456-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2457-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2458-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2459-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2460-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2461-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24
Z-2462-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-24

Product code MNI

K110497Class IIPass Lp Spinal SystemMedicrea International / cleared 2011-09-26

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)