Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
FDA device recall Z-0492-2015 · posted 2015-01-09 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- 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.
- Action taken
- Ethicon sent an Urgent Medical Device Recall Letter/Business Reply Form dated 10/17/2014 via UPS next day mail.
- Root cause
- Other
- Status
- Terminated
- Product code
- GAP
- Quantity affected
- 2,508 each
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-10-17
- Date posted
- 2015-01-09
- Date terminated
- 2015-08-14
- Location
- Somerville, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK (K946173) | ETHICON, Inc. | 1995-01-09 |