META-TAN Screw Kit (Smith & Nephew) – compression screw issue (2025)
Hazard assessment based on recall description.
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
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Products Sold
UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Smith & Nephew, Inc. is recalling META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690 due to Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Recommended Action
Per FDA guidance
On 3/18/2025, recall notices were mailed and emailed to customers who were asked to do the following: 1) Inspect your inventory and locate any affected devices and quarantine them. 2) If you are a sales rep, district office, or distributor, you must notify your customers of the field action and ensure that the required actions are complete. 3) Complete and return the notice response section via email to FieldActions@smith-nephew.com If you have any questions email the firm at the email address above.
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