medical Class II Updated 2022-05-18

Ethicon, Inc. recalls STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A

Recalled Product

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].


Hazard / Issue

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

Issued by

FDA

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
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