Recall Z-0597-06 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Inc.
Zimmer Natural Hip System Collarless Stem, porous, with HA coating for cementless use only, sterile, Size 3, Right; Ref 7356-02-103.
| Date | Mar 7, 2006 (initiated Feb 22, 2006) |
| Status | Terminated |
| Reason | Misbranded-The package actually contains an APR hip system, HA porous stem, 12 mm, left. |
| Root cause | Other |
| Action | Firm''s sales representatives were notified via email on 2/22/06 to visit the customers, remove the product from inventory, and to return it to the firm. |
| Quantity | 5 |
| Distribution | Arizona, Wisconsin and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920955 | APR(R) HIP SYST & NATURAL-HIP(R) FOR UNCEMENT USE Intermedics Orthopedics, Feb 9, 1994 |