Recalls / —

—#217503

Product

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

FDA product code

HWC — Screw, Fixation, Bone

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K080358, K142948

Affected lot / code info

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

Why it was recalled

Removal of affected lot of screws due to labeling error.

Root cause (FDA determination)

Packaging process control

Action the firm took

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 FieldActions@smith-nephew.com 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 FieldActions@smith-nephew.com.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

130 & 120 Forbes Blvd, Mansfield, Massachusetts 02048

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2025-11-24

Posted by FDA

2025-12-18

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #217503. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.