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BIOSURE recallZ-0957-2026 · Smith & Nephew, Inc. · initiated Nov 24, 2025

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

Removal of affected lot of screws due to labeling error.

FDA root cause category: Packaging process control

What the company is doing

An "Urgent Medical Device Recall Notice" dated 11/24/25 was sent to consignees via post and email. The notice instructs consignees to inspect their inventory and quarantine any devices identified in the notice. Consignees with product to return should complete the provided response form as instructed to facilitate return. Completed forms are to be sent to [email protected] in order to obtain a Return Authorization. Consignees with no product to return are to return the provided form indicating as such. If a consignee is a sales representative, district office, or distributor they are to forward the provided notice to their customers. Questions can be directed to [email protected].

Recall details

Recall number
Z-0957-2026
Status
Open, Classified
Initiated by the company
Nov 24, 2025
Posted by the FDA
Dec 18, 2025
Recalling firm
Smith & Nephew, Inc.
Quantity
168 units (US 83; OUS 85)
Product code
HWC
FDA submissions
K080358, K142948
Distribution
US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.

Product description

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Code information (models, lots, serial numbers)

Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

39 devices cleared under K080358, K142948 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

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