FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
- Recall number
- Z-1738-2019
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420323 Phase 3 Femoral Drill Guide Large
- Status
- Terminated
- Initiated
- 2019-04-18
- Posted
- not on file
- Terminated
- 2020-09-10
- Reason
- Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.
- 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
- 11 units
- Distribution
- CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS
- Lot, serial or model codes
- Lot Numbers: ZB161102 ZB170201 ZB170301 ZB170401 ZB170901
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28