SYNTHECEL Dura Repair — Class II medical device recall Z-1386-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-04-20, distributed nationwide. It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation
| Recall number | Z-1386-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-12-08 |
| Classified | 2016-04-13 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 378 units |
| Reason classes | labeling |
| Lot numbers | 7840501, 7855340, 7860569, 7880951, 7900040, 7909689, 7922343, 7932422, 7937107, 9800722, 9813796, 9862235 |
| Model numbers | SC.400.056.01S |
Product
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Reason for recall
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1386-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.