Skip to content

BIORAPTOR recallZ-0581-2025 · Smith & Nephew Inc. · initiated Oct 29, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Package design/selection

What the company is doing

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].

Recall details

Recall number
Z-0581-2025
Status
Open, Classified
Initiated by the company
Oct 29, 2024
Posted by the FDA
Nov 29, 2024
Recalling firm
Smith & Nephew Inc.
Quantity
2,156 units
Product code
MBI
FDA submissions
K071586, K152566
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 description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

4 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

10 devices cleared under K071586, K152566 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page