Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Reported: July 28, 2021 Initiated: June 14, 2021 #Z-2107-2021
Product Description
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
Reason for Recall
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Details
- Recalling Firm
- Arthrex, Inc.
- Units Affected
- 3985 pieces
- Distribution
- US Nationwide Distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC. Recalled by Arthrex, Inc.. Units affected: 3985 pieces.
Why was this product recalled? ▼
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 28, 2021. Severity: Moderate. Recall number: Z-2107-2021.
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