FDA Medical Device Recalls (openFDA)
Arthrex, Inc.: Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- Recall number
- Z-2107-2021
- Recalling firm
- Arthrex, Inc.
- Product
- Suture Anchor, BioComposite SwiveLock C, 5.5 mm x 19.1 mm, Closed Eyelet, REF AR-2323BCC
- Status
- Open, Classified
- Initiated
- 2021-06-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.
- Root cause
- Under Investigation by firm
- Action
- On June 14, 2021 the firm e-mail their consignees with the following instructions: Immediately discontinue use, sale, and distribution of the affected lots of product. and to contact the Field Logistics Services at FLS@arthrex.com to answer questions regarding credit for affected devices in your possession.
- Quantity
- 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.
- Lot, serial or model codes
- Lots 12758314 and 13022357
- 510(k) numbers
- ["K203495"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1220246
- Firm city
- Naples
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28