Recall Z-1543-2011 ยท HTO Reamer
Biomet, Inc.
Cylindrical Bullet Nose Reamer 17.5 mm x 250 mm, REF 475823, Biomet Orthopedics 66 East Bell Drive Warsaw IN. The product is used to prepare the femoral canal for stem implantation.
| Date | Mar 4, 2011 (initiated Dec 23, 2010) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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 Respo |
| Distribution | Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.