Reported May 18, 2022 · Ongoing
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…
Ethicon, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ethicon, Inc. · Us Highway 22 West · Somerville, NJ · 08876
Is this the product you have?
- STRATAFIX SPIRAL PGA-PCL UNI UD sizes[20CM USP2-0(M3) S/A RB-1
- product codeSXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1
- product codeSXMD1B100-12]
- Lot codes and dates
- Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
- Amount recalled
- 2808 (all OUS)
Why it was recalled
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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