STRATAFIX Absorbable Sutures Recalled for Wrong Needle Type
Ethicon recalls STRATAFIX absorbable sutures after discovering some packages contain the wrong needle type. The PS-1 cutting edge needle instead of the intended SH taper point needle may cause more tissue trauma than anticipated.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II device recall with a risk-of-harm condition (wrong needle type causing tissue trauma) but no reported injuries or illnesses. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Ethicon, Inc. is recalling STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. sutures (Product No. SXMD1B405-12) indicated for soft tissue approximation in surgery. Some packages in affected lot B903HPU may contain a PS-1 cutting edge needle instead of the intended SH taper point needle.
The PS-1 cutting edge needle may cause more tissue trauma than anticipated for taper point needles during surgical use, potentially necessitating additional repair procedures. This presents an unexpected surgical complication risk.
The affected product was distributed internationally to China. Healthcare facilities that received this lot should verify needle type before use.
Ethicon recommends users inspect packages to confirm the correct needle type is present before surgical use. If the incorrect needle has been used, surgical teams should monitor for unexpected tissue trauma and contact Ethicon or the FDA to report any adverse events.
The recalled product
- Product
- STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12
- Manufacturer
- Ethicon, Inc.
- Hazard
- wrong-needle
- tissue-trauma
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
Distribution
Distribution scope not specified by the agency.
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