Device recall
Z-1636-2010: ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT…
FDA device recall · Class II · Wright Medical Technology Inc
Key facts
| Recall number (Z-number) | Z-1636-2010 |
|---|---|
| Recall event | 55436 |
| Product | ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature… |
| Product code | JWH |
| Recalling firm | Wright Medical Technology Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2010 |
| 510(k) numbers | K972770 |
| FEI number | 1043534 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database