Ethicon PERMA-HAND Silk siliconized black braided 10… recallZ-0492-2015 · Ethicon, Inc. · initiated Oct 17, 2014
Class II Terminated All recalls posted in January 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ethicon, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.
FDA root cause category: Other
What the company is doing
Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.
Recall details
- Recall number
- Z-0492-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 17, 2014
- Posted by the FDA
- Jan 9, 2015
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2,508 each
- Product code
- GAP
- FDA submissions
- K946173
- Distribution
- Nationwide Distribution
Product description
Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
Code information (models, lots, serial numbers)
PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q06 Lots and Expiration Dates- GPP528 JUL 2018 GPP908 JUL 2018 HAB605 JAN 2019 HAE019 JAN 2019 HAE964 JAN 2019 HAP987 JAN 2019 HBB681 JAN 2019 HBB952 JAN 2019 HBE186 JAN 2019 HCB084 JAN 2019 HCB972 JAN 2019 HCE266 JAN 2019 HCE980 JAN 2019 PERMA-HAND" Silk Suture [Siliconized black braided] Product Code - 10Q07 Lots and Expiration Dates- GPB984 JUL 2018 GPE919 JUL 2018 HAP822 JAN 2019 HBP781 JAN 2019 HCP953 JAN 2019 HCR677 JAN 2019
Other devices under the same FDA submission
457 devices cleared under K946173 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ETHILON 697GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE223 reports
- ETHIBOND EXCEL X557HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE187 reports
- PERMA-HAND SA86GEthicon, LLC · SUTURE, NONABSORBABLE, SILK120 reports
- ETHILON 698GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE119 reports
- ETHILON 1696GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE118 reports
- VICRYL V960GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall55 reports
- ETHICON M660GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE102 reports
- PERMA-HAND K833HEthicon, LLC · SUTURE, NONABSORBABLE, SILK1 recall46 reports
- ETHILON 699GEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall34 reports
- ETHILON 1669HEthicon, LLC · SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE1 recall30 reports
- VICRYL V449GEthicon, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID74 reports
- ETHICON M650GEthicon, LLC · SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE68 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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