Reported Apr 24, 2024 · Ongoing
STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD…
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. · 1000 Route 202 · Raritan, NJ · 08869-1425
Is this the product you have?
- STRATAFIX Spiral MONOCRYL Plus Bidirectional
- Knotless Tissue Control DeviceSTRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate
- Product CodeSXMP2B412
- Lot codes and dates
- UDI/GTIN30705031464289 (box) 10705031464285 (pouch)
- Lot NumberSHBAEC Exp
- Date
June 302024
- Amount recalled
- 395 units
Where it was sold
Why it was recalled
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
This product could cause temporary or reversible health problems — stop using it.
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