—#85909

Product

Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers.

FDA product code: FZX — Guide, Surgical, Instrument
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Number 087190.

Why it was recalled

Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.

Root cause (FDA determination)

Process control

Action the firm took

An "Urgent Medical Device Recall Notice" dated August 6, 2009 was issued to consignees. The letter described the affected product, issue and actions for consignees. Customers were instructed to complete and return the "FAX back Response Form" (fax number 1-574-372-1683) and all affected product in inventory to Biomet Orthopedics. Direct questions related to the recall notification by calling at 1-800-348- 9500 or 1-574-372-3983, Monday through Friday, 8AM to 5PM.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: United States (Florida and Pennsylvania).

Timeline

Recall initiated: 2009-08-06
Posted by FDA: 2009-11-19
Terminated: 2010-10-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.