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].
- Company
- Ethicon, Inc. Us
- Recall Initiated
- March 24, 2022
- Recall Number
- Z-1053-2022
- Quantity
- 2808 (all OUS)
- Firm Location
- Somerville, NJ
Reason for Recall
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
Distribution
International distribution in the country of China.
Lot / Code Info
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Root Cause
Employee error
Action Taken
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.
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