Smith & Nephew, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0957-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 24, 2025

Date Posted: December 24, 2025

Recall Number: Z-0957-2026

Event ID: 98051

Reason for Recall:

Removal of affected lot of screws due to labeling error.

Status: Ongoing

Product Quantity: 168 units (US 83; OUS 85)

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated