Ethicon PERMA-HAND Silk siliconized black braided 10 strands per… — Class II medical device recall Z-0492-2015
Terminated recall by Ethicon, Inc., reported 2014-12-10, distributed nationwide. Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility
| Recall number | Z-0492-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Somerville, NJ, United States |
| Recall initiated | 2014-10-17 |
| Classified | 2014-12-01 |
| Reported by FDA | 2014-12-10 |
| Terminated | 2015-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 2,508 units |
| Reason classes | sterility |
| Lot numbers | GPB984, GPE919, GPP528, GPP908, HAB605, HAE019, HAE964, HAP822, HAP987, HBB681, HBB952, HBE186, HBP781, HCB084, HCB972, HCE266, HCE980, HCP953, HCR677 |
Product
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Reason for recall
Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
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-0492-2015. 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.