Z-2157-2024Class II

OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM

Name: Z-2157-2024 OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Creator: Exactech, Inc.
Published: 2024-04-18
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2024-04-18 / Open, Classified / root cause: packaging

FDA source

Exactech, Inc. began a recall of OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM on 2024-04-18. FDA classified it as Class II and gives the reason as "Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags". 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-2157-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-06-18
Recalling firm: Exactech, Inc.
Product: OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Exactech issued an URGENT VOLUNTARY MEDICAL DEVICE RECALL to its sales representatives on 04/12/2024. The notice explained the issue with the device, clinical impact (risk), and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Send all affected product back to Exactech as outlined in the attached Recall Confirmation Form . The firm notified the surgeons, hospitals, and healthcare professionals on 04/18/2024. That notice also explained the issue, clinical impact (risk) and requested the following: Actions to be Taken " Review this notification thoroughly. " Immediately discontinue use and quarantine any affected product. " Contact your Exactech Representative. Your local agent will help determine if you have any remaining affected product and remove from your inventory.
Distribution: Worldwide distribution.
Product codes and lots: a) 200-05-23, UDI/DI 10885862039835, Lot Numbers: b) 200-05-26, UDI/DI 10885862039842, Lot Numbers: c) 200-05-29, UDI/DI 10885862039859, Lot Numbers:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2157-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2155-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18
Z-2156-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18
Z-2157-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18
Z-2158-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-18

Product code JWH

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)