The Recall Desk
HighFDA (Devices)·Z-2107-2021·Announced 2021-07-28

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.

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: 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.
Category
Medical Device — Surgical / Orthopedic
Hazard
  • sterilization-failure

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

Distributed nationwide across the United States.

Related recalls

Same category