Recall Z-1806-2025
Smith & Nephew, Inc. · initiated March 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Codes / lots: UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034
Reason for recall
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1806-2025
- Initiated
- March 18, 2025
- Posted by FDA
- May 19, 2025
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 75
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH, NY, AL, IA, MA, NV, MO, WA, LA, TN, NC, KY, NM, NJ, AZ and the country of ZA.
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN