BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT a

FDA device recall Z-2206-2010 · posted 2010-08-11 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.

Action taken

Biomet Microfixation is recalling their 1.5x4mm HT X-drive Screws Lot Number 148530 after receiving a customer reported finding one 3.5MM screw in a package labeled as containing 4.0MM screws. Lot 148530 was packaged into one count packages 91-1504 and 5 count packages 95-1504. The 1 and 5 count packages were distributed between 12/10/2009 and 02/01/2010. Beginning on 03/17/2010 customers identified as receiving Lot 148530 HT X-drive Screws were notified of the recall by a combination of an Urgent Medical Device Recall Notice letter, e-mail, fax and telephone calls. Customers were instructed to inspect their inventory and to return any affected products. They were instructed to complete the attached Inventory Reconciliation sheet and to fax it to Biomet Microfixation. Customers were also instructed to contact any customers to whom they may have further distributed the product. Questions should be directed to Christy Cain at 1-800-874-7711 or 904-741-4400, ext. 468.

Root cause

Other

Status

Terminated

Product code

DZL

Quantity affected

1247 screws

Distribution

Worldwide Distribution -- USA, including states of FL, GA, IN, LA, MD, MI, MO, NC, NY, OK, TX, and VA and countries of Philippines, Japan, Brazil, and Canada.

Date initiated

2010-03-17

Date posted

2010-08-11

Date terminated

2010-08-11

Location

Jacksonville, FL

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