Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled
Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with reported injuries (fascial dehiscence), which meets the criteria for a Severe rating under the rubric.
Plain-English summary
Ethicon, Inc. is recalling the Stratafix Symmetric PDS Plus Knotless Tissue Control Device. The device is intended for general soft tissue approximation where the use of an absorbable suture is appropriate.
The recall is being conducted because of a small number of reported tab failures and fascial dehiscences in lower abdominal incisions. The affected products are identified by product codes beginning with SXPP1A, specifically K113004 and D183642.
A total of 37,164 units were distributed nationwide in the United States and in the Caribbean, Chile, Singapore, and Malaysia. Healthcare providers and facilities should stop using the affected devices and contact Ethicon for further instructions.
The recalled product
- Product
- Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Affected units
- 37,164
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)
- K113004 D183642 All product codes beginning with SXPP1A.
Distribution
Distributed nationwide across the United States.
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