Recall Z-2557-2011 ยท ISL Joint, Hip, External Limb Component
Stryker Howmedica Osteonics Corp.
Accolade TMZF Plus Hip Stem: Catalog # 3020-0537 Accolate d TMZF Hip Stem # 5 Catalog #6020-3535 Accolade 132 Size 3.5 Catalog # 6021-0230 Accolade Plus TMZF Hip Stem #2 Catalog # 6021-0335 Accolade Plus TMZF Hip Stem #3 Catalog #3021-0435 Accolade TMZF Hip Stem #4 Catalog # 6021-0435 Accolade Plus TMZF Hip Stem #4 Catalog #6021-2530 Accolade (127 deg) Size 2.5 Accolade (127 deg) Siz
| Date | Jun 13, 2011 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | Accolade TMZF Plus Hip Stems are being recalled due to grit blast media which was observed in the drive hole. |
| Root cause | Employee error |
| Action | Stryker Orthopaedics sent an Urgent Product Recall letter dated March 1, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to fax back the attached Product Recall Acknowledgement Form within 5 days to 201-831-6069. Customers were also instructed to: Contact the hospitals in their territory that have the affected product to arrange return of the product. Return the affected product via and Inter-Org Transfer to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, |
| Quantity | total of all units is 44 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |