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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 08, 2022
Create Date September 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-1773-2022
Recall Event ID 90764
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product PDS II (polydioxanone) Suture, Product Code Z771D

4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
Code Information UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information Contact
908-218-0707
Manufacturer Reason
for Recall		 Product may contain the incorrect material which could impact treatment.
FDA Determined
Cause 2		 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 in Commerce 88 boxes (1056 ea)
Distribution Distribution in Japan only
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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