FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Recall number
- Z-1773-2022
- Recalling firm
- Ethicon, Inc.
- Product
- PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Status
- Open, Classified
- Initiated
- 2022-08-08
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product may contain the incorrect material which could impact treatment.
- Root cause
- Process control
- Action
- Customer notification began August 8, 2022. The responsible Johnson & Johnson affiliates in Japan will be contacting all their impacted primary and secondary consignees and/or end customers. Customers are asked to immediately check inventory for impacted product and to quarantine that product. In the event product has been forwarded to another facility, the customer shall contact that facility to arrange return. The customer shall complete the Business Reply Form (BRF) to confirm receipt of the recall notice within 3 business days. Customers are required to return unused impacted product per the recall letter instructions.
- Quantity
- 88 boxes (1056 ea)
- Distribution
- Distribution in Japan only
- Lot, serial or model codes
- UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEW
- 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