Recall Z-1960-2010
Stryker Spine · initiated May 13, 2010
Product
Stryker 10 MM AVS TL Trial Spacer; Catalog number: 48389410. Manufactured by: Stryker Spine SAS, Cestas, France; Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401. Intended for use in the thoraco-lumbar spine.
Codes / lots: Lot numbers: 063934 - 066350 - 067530 - 06D470 - 071446 - 072674 - 074599 - 075342 - 076571 - 07C636 - 07D771 - 07H718 - 082966 - 084252.
Reason for recall
Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the trialling step of the AVS TL procedure.
FDA-determined cause: Process control
Action taken
Urgent Product Recall letters, dated May 13, 2010 were sent via Federal Express to all direct accounts (branches and hospitals) with a separate letter to surgeons. The letter identified the affected product and also described the issue, potential hazards, and risk mitigations. The letter also asked customers to quarantine any affected product and return to Stryker Spine. A Customer Response Form was provided and customers should contact their Stryker Spine Sales Rep for additional information on replacement product. Questions should be directed to Tiffani Rogers on 201-760-8206.
Details
- Recall number
- Z-1960-2010
- Initiated
- May 13, 2010
- Posted by FDA
- July 8, 2010
- Terminated
- September 6, 2012
- Product code
- MDM – Instrument, Manual, Surgical, General Use
- Quantity
- 193 units
- Distribution
- Nationwide Distribution.
- Recalling firm
- Stryker Spine, Allendale, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1957-2010 | Stryker 7 MM AVS TL Trial Spacer; Catalog number: 48389407. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1958-2010 | Stryker 8 MM AVS TL Trial Spacer; Catalog number: 48389408. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1959-2010 | Stryker 9 MM AVS TL Trial Spacer; Catalog number: 48389409. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1961-2010 | Stryker 11 MM AVS TL Trial Spacer; Catalog number: 48389411. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1962-2010 | Stryker 12 MM AVS TL Trial Spacer; Catalog number: 48389412. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1963-2010 | Stryker 13 MM AVS TL Trial Spacer; Catalog number: 48389413. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1964-2010 | Stryker 14 MM AVS TL Trial Spacer; Catalog number: 48389414. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1965-2010 | Stryker 15 MM AVS TL Trial Spacer; Catalog number: 48389415. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1966-2010 | Stryker 16 MM AVS TL Trial Spacer; Catalog number: 48389416. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1967-2010 | Stryker 17 MM AVS TL Trial Spacer; Catalog number: 48389417 Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |
| Z-1968-2010 | Stryker 18 MM AVS TL Trial Spacer; Catalog number: 48389418. Manufactured by: Stryker…Stryker Spine has received reports of breakage of the distal end of the AVS TL Spacer Trial during the… | 05/13/2010Terminated |