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Ethicon, Inc. recalls 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 P
Recalled May 18, 2022 · FDA recall Z-1053-2022 · Ethicon
Hazard
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up. · FDA Class II
Units
2808 (all OUS)
Sold at
International distribution in the country of China.
Description
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
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].
Manufacturer(s)
Ethicon, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →