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U.S. Department of Health and Human Services

Class 2 Device Recall STRATAFIX SPIRAL PGAPCL

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 Class 2 Device Recall STRATAFIX SPIRAL PGAPCLsee related information
Date Initiated by FirmSeptember 20, 2022
Date PostedOctober 31, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0150-2023
Recall Event ID 90890
510(K)NumberK151200 
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductSTRATAFIX 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
Code Information UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Recalling Firm/
Manufacturer		 Ethicon, Inc.
Us Highway 22 West
Somerville NJ 08876
For Additional Information ContactSAME
908-218-0707
Manufacturer Reason
for Recall		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
FDA Determined
Cause 2		Under Investigation by firm
ActionEthicon 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 in Commerce2,280 eaches
DistributionInternational distribution of the country of China.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GAM
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