Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
Enforcement
- Recall Number
- Z-0393-2014
- Event ID
- 66551
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Synthes USA HQ, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2013
- Initiation Date
- October 15, 2013
- Classification Date
- November 26, 2013
- Termination Date
- August 31, 2015
- Address
- 1302 Wrights Ln E, N/A, West Chester, PA, 19380-3417, United States
Description
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.
One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.
part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206).
Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.
approximately 44