Ethicon STRATAFIX Surgical Sutures Recalled for Incorrect Needle Type and Size
Ethicon is recalling STRATAFIX surgical sutures (lots AAHM529 and AAHQ049) due to component mix-ups resulting in incorrect needle types, sizes, or suture lengths. 2,808 units distributed internationally are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall of surgical sutures with manufacturing defects (incorrect needle types, sizes, or suture lengths). While surgical sutures represent a risk-of-harm product in surgical settings, no injuries or illnesses have been reported in the source material.
Plain-English summary
Ethicon, Inc. is recalling certain STRATAFIX SPIRAL PGA-PCL UNI UD surgical sutures in two affected sizes (product codes SXMD1B403-12 and SXMD1B100-12). The affected lots are AAHM529 and AAHQ049, comprising 2,808 units distributed internationally.
The recall was initiated because affected product lots may contain incorrect needle types, sizes, or suture lengths due to a component mix-up. This deviation from product specifications could compromise proper surgical use of the sutures.
Healthcare facilities with these products should identify affected lot numbers and quarantine the affected sutures. Contact Ethicon for instructions regarding replacement or return of affected products.
The recalled product
- 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
- Ethicon, Inc.
- Affected units
- 2,808
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 (3)
- Lot AAHM529
- UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049
- UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
Distribution
Distribution scope not specified by the agency.
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