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Open, Classified

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

FDA Recall Z-0150-2023 · Posted 2022-10-31

Recalling FirmEthicon, Inc.
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2022-09-20
Product Quantity2,280 eaches

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

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

Root Cause

Under Investigation by firm

Distribution Pattern

International distribution of the country of China.

Official Source

View FDA Recall →

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

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