Recall Z-2179-2008 ยท HRS Plate, Fixation, Bone
Zimmer Inc.
Zimmer 4.5 Compression plate-broad, 10 hole, 167 MM length, stainless steel, non sterile, Manufactured at Zimmer; REF 4945-10-01. The product is used for stabilization of fractures during the normal healing process.
| Date | Sep 11, 2008 (initiated Jun 9, 2008) |
| Status | Terminated |
| Reason | An impurity in the metal may affect the strength of the plate or biocompatibility of the material with the body. |
| Root cause | Material/Component Contamination |
| Action | Zimmer Thailand was notified via an emailed letter dated 6/9/08 to check for inventory at all customer accounts and to return the product. Contact Zimmer at 1-574-371-8028 for assistance. |
| Quantity | 7 |
| Distribution | International Distribution --- including Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.