Lower riskMedical device recall · FDA · Published November 24, 2025
Smith & Nephew BIOSURE HA Screw Recall: Labeling Error Risk
Smith & Nephew recalls BIOSURE HA screws with labeling errors. Affected screws may be misidentified, leading to improper use in hip replacements. Contact for details.
Smith & Nephew is recalling certain BIOSURE HA screws due to a labeling error that could lead to improper identification and use in hip replacements. This affects patients who received the specific model numbers and batch dates listed in the recall. Read more at govinfonow.com/recall/50608-smith-nephew-biosure-ha-screw-recall-labeling-error-risk.
“Smith & Nephew BIOSURE HA Screw Recall: Labeling Error Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50608-smith-nephew-biosure-ha-screw-recall-labeling-error-risk. Based on FDA recall #Z-0957-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0957-2026%22&limit=1).
Smith & Nephew, Inc. recalled BIOSURE HA SCREW, 6MM x 20 MM due to a labeling error, according to the FDA on 2025-11-24.
How to tell if you have it
Brand: Smith & Nephew, Inc.
Product: BIOSURE HA SCREW, 6MM x 20 MM
Model No.: 72201768, 72204389
UDI: 03596010611642, 00885554036572
Batch No.: 51315219, 51306803
The hazard
The recall involves removal of the affected lot of screws due to a labeling error.
Context
GovInfoNow's records show Smith & Nephew, Inc. has 66 other recalls on record since 2017-07-24. Other recent recalls include the Smith & Nephew TRIGEN Humeral Nail Recall (2026-03-16), the Smith & Nephew META-TAN Screw Kit Recall (2025-03-18), and the Smith & Nephew BIORAPTOR Suture Anchors recall (2024-10-29). Other recent recalls of similar products include the Tornier Perip Screw Recall (2025-12-19), the Encore Medical RSP Humeral Socket Insert Recall (2026-01-15), and the XTANT Medical Xpress Pedicle Screw System recall (2026-02-18).
How to tell if you have this one
Check for model numbers 72201768 or 72204389 and batch numbers 51315219 or 51306803 on the screws. The screws are threaded metallic bone fixation fasteners used in hip replacements.
Brand
Smith & Neph: Inc.
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Screw Labels
Look for model numbers 72201768 or 72204389 and batch numbers 51315219 or 51306803 on the screws.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Illinois, Iowa, Kentucky, Minnesota, Nebraska, New York, North Carolina, Oklahoma, Tennessee, Texas, Utah.
Recall timeline
FDA published this recall 30 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0957-2026 (November 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0957-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.