FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc.: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Recall number
- Z-0581-2025
- Recalling firm
- Smith & Nephew Inc.
- Product
- BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
- Status
- Open, Classified
- Initiated
- 2024-10-29
- Posted
- 2024-11-29
- Terminated
- not on file
- Reason
- Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
- Root cause
- Package design/selection
- Action
- An URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to FieldActions@smith-nephew.com. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questions about this recall are to be emailed to FieldActions@smith-nephew.com.
- Quantity
- 2,156 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
- Lot, serial or model codes
- Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
- 510(k) numbers
- ["K071586","K152566"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- 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