Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

FDA Recall Z-1773-2022 · Posted None

Recalling FirmEthicon, Inc.
Recall StatusOpen, Classified
Product CodeNEW
Date Initiated2022-08-08
Product Quantity88 boxes (1056 ea)

Reason for Recall

Product may contain the incorrect material which could impact treatment.

Firm 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.

Root Cause

Process control

Distribution Pattern

Distribution in Japan only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑