FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
- Recall number
- Z-0150-2023
- Recalling firm
- Ethicon, Inc.
- Product
- STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
- Status
- Open, Classified
- Initiated
- 2022-09-20
- Posted
- 2022-10-31
- Terminated
- not on file
- Reason
- Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- Root cause
- Under Investigation by firm
- Action
- Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations
- Quantity
- 2,280 eaches
- Distribution
- International distribution of the country of China.
- Lot, serial or model codes
- UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
- 510(k) numbers
- ["K151200"]
- PMA numbers
- not on file
- Product code
- GAM
- 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