Z-0393-2014 Class II Terminated
FDA device recall Z-0393-2014 was initiated by Synthes USA HQ, Inc. on Oct 15, 2013 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Aug 31, 2015). Affected quantity: approximately 44.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 4, 2013
- Initiation Date
- Oct 15, 2013
- Termination Date
- Aug 31, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- approximately 44
Product 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.
Reason for Recall
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.
Distribution Pattern
Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.
Code Information
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).