Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The mu
FDA device recall Z-0824-2015 · posted 2014-12-17 · Terminated
Recall details
- Recalling firm
- Zimmer Manufacturing B.V.
- Reason for recall
- Analysis of returned complaint devices, product in inventory, and device manufacturing records has identified tool marks isolated to one specific machining mill to be the cause of the fractures. .
- Action taken
- Zimmer sent an Urgent Medical Device Recall letter dated November 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel were aware of the contents. Customers were advised to quarantine any affected product and notify their Zimmer sales representative who will remove the recalled product from their facility. For patients who previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 6,377
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada Australia Brazil Chile China Colombia Japan Malaysia Singapore South Korea Taiwan Albania Austria Belgium Bulgaria Canary Island
- Date initiated
- 2014-11-21
- Date posted
- 2014-12-17
- Date terminated
- 2015-08-10
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRILOGY ACETABULAR SYSTEM (K934765) | Zimmer, Inc. | 1994-04-29 |