Surgical Sutures Recalled for Sterility Compromise During Transit
Ethicon recalls 395 units of STRATAFIX surgical sutures (lot SHBAEC) due to sterility compromise from environmental exposure during transit and storage. Product is unsuitable for surgical use.
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 Class II medical device recall involves compromised sterility of a surgical suture product, presenting a risk of surgical site infection or other complications. No illnesses or injuries have been reported, and per the rubric, recalls without reported hospitalization do not exceed severity level 3.
Plain-English summary
Ethicon, Inc. is recalling 395 units of STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device (surgical sutures), product code SXMP2B412. The affected lot is SHBAEC with an expiration date of June 30, 2024.
The sutures were found to be degraded and unusable upon removal from the foil pouch due to environmental exposure during transit and storage. This environmental exposure compromises the sterility of the product, which is essential for safe use in soft tissue approximation procedures.
The recalled units were distributed to healthcare facilities in Colorado, Georgia, Iowa, Michigan, New Jersey, New York, Pennsylvania, South Carolina, and Wisconsin.
Healthcare providers should immediately stop using the affected lot and contact Ethicon, Inc. for replacement or proper disposal instructions. Any units bearing lot number SHBAEC should not be used in surgical procedures.
The recalled product
- Product
- STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX 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 Code…
- Manufacturer
- Ethicon, Inc.
- Hazard
- Affected units
- 395
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)
- 2024
Distribution
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