Stryker Orthopaedics Bone Screw; Dia 6.5 mm; Lnth: 25 mm; Sterile: Made in the USA; Stryker Osteonics Corp. 325 Corporat
FDA device recall Z-2132-2009 · posted 2009-09-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Raw material supplied by a third party used to manufacture various medical devices does not comply with metallurgical requirements outlines in ASTM standard for titanium surgical implants.
- Action taken
- Stryker Orthopaedics issued "Urgent Product Recall" letters via Federal Express priority overnight beginning June 26, 2009 to Branches, Hospital Risk Management and Chief of Orthopaedics and Surgeons. All users are requested to examine their inventory, retrieve all affected product and return for reconciliation to Stryker Orthopaedics. Users are also requested to complete the enclosed Product Accountability Form and fax with necessary information to the firm at 1-201-831-6069. For further information, contact Stryker Orthopaedics at 1-201-831-5970.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 51,113 total - all sizes.
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-06-26
- Date posted
- 2009-09-14
- Date terminated
- 2010-07-27
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIFIT BONE SCREW (K873251) | Osteonics Corp. | 1987-09-18 |