Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile; Manufactured for: Stryker Spine SAS, Cestas, France; Distributed in the US by Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation.
- Company
- Stryker Spine
- Recall Initiated
- January 18, 2010
- Posted
- February 16, 2010
- Terminated
- September 6, 2012
- Recall Number
- Z-0790-2010
- Quantity
- 2727 total, all sizes
- Firm Location
- Allendale, NJ
Reason for Recall
Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
Distribution
Nationwide distribution.
Lot / Code Info
Catalog number: 48237105; all lots
Root Cause
Package design/selection
Action Taken
Stryker Spine issued an "Urgent Product Recall" notification dated January 15, 2010 via Federal Express to all consignees. The letter informed users of the issue and potential hazards of the affected product. For further information, contact your local Stryker Spine Sales Representative or call 201-760-8206.