ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medi
FDA device recall Z-1636-2010 · posted 2010-05-21 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The left medial pivot and right medial pivot inserts were co-mingled
- Action taken
- Wright Medical Technology, Inc. issued an "Urgent: Medical Device Voluntary Recall" notification dated November 24, 2009. The letters were addressed to distributors, hospital administrators, and surgeons. Consignees were asked to return all affected product in addition to a completed Response Form to the firm. For further information, contact Wright Medical Technology, Inc. at 1-800-874-5630.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 23 units
- Distribution
- Worldwide Distribution -- United States, The Netherlands, Italy, Republic of Korea and Japan.
- Date initiated
- 2009-11-24
- Date posted
- 2010-05-21
- Date terminated
- 2010-10-21
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCE ULTRA-CONGRUENT TIBIAL INSERT (K972770) | Wrightmedicaltechnologyinc | 1997-10-21 |