Z-1018-2023Class II

Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when...

Name: Z-1018-2023 Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when...
Creator: Biomet, Inc.
Published: 2022-12-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2022-12-15 / Open, Classified / root cause: packaging

FDA source

Biomet, Inc. began a recall of Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial... on 2022-12-15. FDA classified it as Class II and gives the reason as "Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and...". 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-1018-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-01-26
Recalling firm: Zimmer GmbH
Product: Oxford Partial Knee System, Fixed Lateral Tibial Construct- Intended to replace part of a knee joint when used in conjunction with a femoral and tibial component Item Number: 154341
Product code: HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: Packaged in the incorrect shelf carton. Incorrect shelf carton; outer carton is smaller than the required outer carton, which forces the Tyvex pouch to be folded and packaged in the carton causing compound creases and compromise the sterile barrier
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Zimmer Biomet issued Urgent Medical Device Recall Letter on 12/15/22 to Distributors and Risk Managers/Surgeons. Letter states reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 7 units
Distribution: Worldwide distribution - US Nationwide distribution in the states of IN, KY and the countries of Canada, New Zealand, Japan, Netherlands.
Product codes and lots: UDI: (01) 05019279515349 (17) 241123 (10) 077830 Lot Number: 077830

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1018-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1018-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-01	2023-01-26

Product code HRY

K133940Class IIOxford Fixed Lateral Bearing Partial Knee Replacement (Bearings / Trays)Biomet UK, Ltd. / cleared 2014-03-28

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)