Z-0581-2025Class II

BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor

Name: Z-0581-2025 BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor
Creator: Smith & Nephew Inc.
Published: 2024-10-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2024-10-29 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew Inc. began a recall of BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor on 2024-10-29. FDA classified it as Class II and gives the reason as "Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0581-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-29
Posted: 2024-11-29
Recalling firm: Smith & Nephew, Inc.
Product: BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Root cause tag: packaging
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0581-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0581-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-11	2024-11-29

Product code MBI

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)