Recall Z-2779-2011
Biomet Microfixation, Inc. · initiated June 25, 2010
Product
Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***www.biometfixation.com***2.0 MM X 7.0 MM TITANIUM***#01-6577***LOT XXXXXX***QTY 00001***X-DRIVE FOSSA SCREW 5/PKG***2.0 MM X 7.0 MM***". Bone screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system. These screws are to be used with our TMJ (Temporal Mandibular Joint) implants.
Codes / lots: Lot # 233270
Reason for recall
Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm Fossa x-drive screws, 5 pack.
FDA-determined cause: Mixed-up of materials/components
Action taken
Biomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an Inventory Reconciliation form via fax to 904-741-9425. The form requests that customers indicate whether they want to keep the product or return for credit. Customers can contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400 ext. 468 for questions regarding this recall.
Details
- Recall number
- Z-2779-2011
- Initiated
- June 25, 2010
- Posted by FDA
- July 11, 2011
- Terminated
- November 9, 2011
- Product code
- KBW – Screw, Oral
- Quantity
- 25 units
- Distribution
- Product was distributed to one distributor in Argentina.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL