Z-0957-2026Class II

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

Name: Z-0957-2026 BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener
Creator: Smith & Nephew, Inc.
Published: 2025-11-24
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2025-11-24 / Open, Classified / root cause: packaging

FDA source

Smith & Nephew, Inc. began a recall of BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener on 2025-11-24. FDA classified it as Class II and gives the reason as "Removal of affected lot of screws due to labeling error". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0957-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-24
Posted: 2025-12-18
Recalling firm: Smith & Nephew, Inc.
Product: BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Removal of affected lot of screws due to labeling error.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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].
Quantity in commerce: 168 units (US 83; OUS 85)
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 codes and lots: Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0957-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0957-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)