FDA Device recall Z-0393-2014
Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Materia…
- FDA Device
- Class II
- terminated
- Published 2013-12-04
On 2013-12-04 the FDA classified a Class II recall of Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Materia… by Synthes Usa Hq, citing 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 corrosio….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0393-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-15 |
| Published | 2013-12-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T98773…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). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0393-2014%22
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