Recalls / —

—#210894

Product

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

FDA product code

MBI — Fastener, Fixation, Nondegradable, Soft Tissue

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K071586, K152566

Affected lot / code info

Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

Why it was recalled

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Root cause (FDA determination)

Package design/selection

Action the firm took

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.

Recalling firm

Firm

Smith & Nephew Inc.

Address

150 Minuteman Rd, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2024-10-29

Posted by FDA

2024-11-29

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #210894. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.