Recall Z-0790-2010
Stryker Spine · initiated January 18, 2010
Product
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.
Codes / lots: Catalog number: 48237105; all lots
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.
FDA-determined 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.
Details
- Recall number
- Z-0790-2010
- Initiated
- January 18, 2010
- Posted by FDA
- February 16, 2010
- Terminated
- September 6, 2012
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 2727 total, all sizes
- Distribution
- Nationwide distribution.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0789-2010 | Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0791-2010 | Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |
| Z-0792-2010 | Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile; Manufactured for:…Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which… | 01/18/2010Terminated |