Terminated

Labeled in part:"BIOMET MICROFIXATIONBIOMET MICROFIXATION1520 TRADEPORT DRIVEJACKSONVILLE, FL 33218 USAwww.biometfixation.com2.0 MM X 7.0 MM TITANIUM#01-6577LOT XXXXXXQTY 00001X-DRIVE FOSSA SCREW 5/PKG2.0 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.

FDA Recall Z-2779-2011 · Posted 2011-07-11

Recalling FirmBiomet Microfixation, Inc.

Recall StatusTerminated

Product CodeKBW

Date Initiated2010-06-25

Date Terminated2011-11-09

Product Quantity25 units

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.

Firm Action

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.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Product was distributed to one distributor in Argentina.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.