Suture Anchor Products Recalled Due to Improper Sterilization
Arthrex is recalling 3,985 BioComposite SwiveLock C suture anchors due to improper sterilization from seal defects. The affected lots (12758314 and 13022357) were distributed nationwide.
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: FDA Class II medical device recall. The device poses a risk of infection due to improper sterilization, but no illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
Arthrex, Inc. is recalling 3,985 units of the BioComposite SwiveLock C suture anchor (5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC). The affected lots are 12758314 and 13022357.
The suture anchors were not properly sterilized due to a defect in the outer pouch seal. The Tyvek header was sealed too closely to the foil pouch, compromising the sterilization process and creating a potential infection risk for patients receiving the implant.
The product was distributed nationwide across multiple U.S. states and Hawaii.
The recalled product
- Product
- Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 3,985
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)
- Lots 12758314 and 13022357
Distribution
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