Citation TMZF HA Hip Stem - RT. Hip stems are single use devices intended for cementless fixation. The products are inte
FDA device recall Z-1377-2009 · posted 2009-07-22 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
- Action taken
- An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 1,628 total stems, all varieties.
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-01-06
- Date posted
- 2009-07-22
- Date terminated
- 2012-06-25
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CITATION TMZF HA STEM (K993768) | Howmedica Osteonics Corp. | 2000-01-21 |