—#172757

Product

Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420321 Phase 3 Femoral Drill Guide Small

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: ZB160201 ZB160401 ZB161101 ZB170401 ZB170601 ZB170801 ZB170901

Why it was recalled

Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS

Timeline

Recall initiated: 2019-04-18
Terminated: 2020-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172757. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.