Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hi
FDA device recall Z-1043-2015 · posted 2015-02-03 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.
- Action taken
- Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to so_m_product_field_action_response@stryker.com or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- seven units
- Distribution
- Nationwide Distribution including NY, OH, PA, and TX.
- Date initiated
- 2014-12-15
- Date posted
- 2015-02-03
- Date terminated
- 2016-09-22
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM (K983382) | Osteonics Corp. | 1998-12-11 |