BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix... (Smith & Nephew, Inc.) – removal of affected lot of screws due... (2025)
Labeling error can cause minor medical device identification issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
Model No. 72201768, 72204389, UDI: 03596010611642, 00885554036572, Batch No. 51315219, 51306803.
Products Sold
Model No. 72201768, 72204389; UDI: 03596010611642, 00885554036572; Batch No. 51315219, 51306803.
Smith & Nephew, Inc. is recalling BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. due to Removal of affected lot of screws due to labeling error.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Removal of affected lot of screws due to labeling error.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026