Recall Z-1737-2019 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium
| Date | Apr 18, 2019 |
| Status | Terminated |
| 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. Complet |
| Quantity | 10 units |
| Distribution | CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.