Z-1737-2019Class II

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3...

Name: Z-1737-2019 Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3...
Creator: Zimmer Biomet, Inc.
Published: 2019-04-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-04-18 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium on 2019-04-18. FDA classified it as Class II and gives the reason as "Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion". 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-1737-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-18
Posted: 2019-06-06
Terminated: 2020-09-10
Recalling firm: Zimmer GmbH
Product: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL notification to distributors and hospital risk managers on 4/18/19 via FedEX and email. " Distributors letter identifies the issue and responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. Complete Certificate of Acknowledgement. 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.
Quantity in commerce: 10 units
Distribution: CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
Product codes and lots: Lot Numbers: ZB130801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1737-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1736-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1737-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1738-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1739-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1740-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06
Z-1741-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-06

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)