Class II U.S. Food and Drug Administration

Smith & Nephew, Inc. Biosure HA Screw, 6MM x 20 MM. Threaded metallic bone fixation recall: Removal of affected lot of screws due to labeling error

Recall published 10 months ago

Removal of affected lot of screws due to labeling error.

The hazard: Mislabelling or misbranding

Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

What the notice says: Removal of affected lot of screws due to labeling error.

Why it matters: The product carries the wrong label, the wrong lid or the wrong packaging. The food inside is generally fine; the problem is that the package describes something else, which defeats anyone relying on it.

Symptoms and when to call a doctor

There is no illness associated with mislabelling itself. The exception is where the undeclared contents include an allergen, in which case treat it as an allergen recall and watch for the reaction that person normally has.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0957-2026
Published
December 24, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Smith & Nephew, Inc.
Product type
Medical devices
Units affected
168 units (US 83; OUS 85)
Distribution
Nationwide
Made in
United States
Lot / code info
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
UPC codes
03596010611642, 00885554036572

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 03596010611642
  • 00885554036572

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 51315219
  • 51306803. — 168 units

Model or item number

On the rating label, the box or the instruction sheet.

  • 72201768
  • 72204389

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Mislabelled

Smith & Nephew, Inc. — Misbranding prompted this recall. The agency treats a label that misstates the contents as seriously as it treats contamination, because people act on labels.

  1. Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.
  2. If the undeclared contents include an allergen, treat it as an allergen recall and stop serving it to anyone affected.
  3. Return it for a refund; a mislabelled pack is returnable whether or not it is edible for your household.
  4. Keep a photo of the mismatched label, which makes the refund conversation much shorter.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Company contact: Smith & Nephew, Inc. — 130 & 120 Forbes Blvd, Mansfield, MA, 02048

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Smith & Nephew, Inc. medical devices recalled?

Removal of affected lot of screws due to labeling error. Removal of affected lot of screws due to labeling error.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 03596010611642, 00885554036572; lot code 51315219, 51306803. — 168 units; model number 72201768, 72204389. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Read the official notice to see what is actually inside the pack, then decide whether anyone in your home needs to avoid it.

Can I get my money back?

Claim the refund at the store first; it is the fastest route and needs the least paperwork.

Where was the recalled product sold?

It was distributed nationwide.

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