FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
- Recall number
- Z-0747-2019
- Recalling firm
- Ethicon, Inc.
- Product
- PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
- Status
- Terminated
- Initiated
- 2018-12-18
- Posted
- not on file
- Terminated
- 2020-05-29
- Reason
- The sutures inside the packaging are not the same size or type as indicated on the label.
- Root cause
- Packaging process control
- Action
- Ethicon sent an Urgent Medical Device Recall notification letters to customers on 12/18/18. The letter identified the affected product, problem and actions to be taken. For questions contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266).
- Quantity
- 840
- Distribution
- The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI.
- Lot, serial or model codes
- Product Lot MEH906
- 510(k) numbers
- ["K946173"]
- PMA numbers
- not on file
- Product code
- GAP
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28