Labeled in part:"***BIOMET MICROFIXATION***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 33218 USA***ww

FDA device recall Z-2779-2011 · posted 2011-07-11 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

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.

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

KBW

Quantity affected

25 units

Distribution

Product was distributed to one distributor in Argentina.

Date initiated

2010-06-25

Date posted

2011-07-11

Date terminated

2011-11-09

Location

Jacksonville, FL