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Open, Classified

STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

FDA Recall Z-1053-2022 · Posted None

Recalling FirmEthicon, Inc.
Recall StatusOpen, Classified
Product CodeGAM
Date Initiated2022-03-24
Product Quantity2808 (all OUS)

Reason for Recall

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

Firm Action

A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.

Root Cause

Employee error

Distribution Pattern

International distribution in the country of China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122898QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech · 2012-10-22

Official Source

View FDA Recall →

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

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