Recall Z-0475-2008 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Howmedica Osteonics Corp.
Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
| Date | Dec 14, 2007 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted. |
| Root cause | Other |
| Action | Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols. |
| Quantity | 192 protocols |
| Distribution | Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.