—#154315

Product

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

FDA product code: GFG — Bit, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Batch Numbers: G10766, G10782, G18814, G18815, G32178, G32179

Why it was recalled

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Root cause (FDA determination)

Device Design

Action the firm took

Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 130 & 120 Forbes Blvd, Mansfield, Massachusetts 02048

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

Timeline

Recall initiated: 2017-03-15
Terminated: 2018-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154315. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.