Recalls / —
—#96776
Product
Cylindrical Bullet Nose Reamer 19.0 mm x 250 mm, REF 475826, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
- FDA product code
- HTO — Reamer
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- 096540
Why it was recalled
The firm was notified by their supplier that during manufacture of this instrument, the 12 degree cutting edge was not created. Testing found that if the cutting edge is missing, the reamer will not perform as intended.
Root cause (FDA determination)
Other
Action the firm took
The firm, BIOMET, sent an" URGENT MEDICAL DEVICE RECALL NOTICE" dated December 23, 2010 to its customers. The notice described the product, problem and actions to be taken by the customer. The customers were instructed to immediately locate, discontinue use of product and return the product to Biomet. Biomet distributors were told to notify hospital personnel of the recall if they had distributed the product to hospital customers. The Customers/Distributors were instructed to confirm receipt of the notice by calling 800-348-9500 extension 3755 and 3983 and to complete and return the Response Form included with the recall notice via fax to 574-372-1683. Questions related to this notice should be directed to 574-371-3755 or 574-372-3983, Monday through Friday, 8am to 5pm.
Recalling firm
- Firm
- Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
Timeline
- Recall initiated
- 2010-12-23
- Posted by FDA
- 2011-03-04
- Terminated
- 2012-10-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #96776. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.