A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation o
FDA device recall Z-0882-2021 · posted 2021-01-21 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill.
- Action taken
- On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 174 systems
- Distribution
- Nationwide distribution.
- Date initiated
- 2020-12-23
- Date posted
- 2021-01-21
- Date terminated
- 2023-04-13
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A. L. P. S. Clavicle Plating System (K173767) | Biomet, Inc. | 2018-04-06 |