—#213212

Product

META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K092748, K210980
Affected lot / code info: UDI-DI: 00885556132975. Lot: 24CT81426. Expiration: 25-Mar-2034

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-03-18
Posted by FDA: 2025-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213212. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.