BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455

FDA device recall Z-0592-2016 · posted 2016-01-06 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

Inadequate biocompatibility testing.

Action taken

The firm, Biomet 3i, sent an "URGENT DEVICE RECALL NOTICE" letter dated September 16, 2015 to both Domestic and Foreign Customers via traceable courier. The letter described the product, problem and actions to be taken. The customers were instructed to review the notice and check your inventory for the affected units; immediately quarantine and remove all affected products from service; if you have product to return, call Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700 to obtain a CMP# and return affected product to Biomet 3i Returns, 4555 Riverside Dr., Palm Beach Gardens, FL 34410; complete and return the attached Business Reply Form via fax to: +1-561-514-6316 or email to: postmarket@biomet.com, and maintain a copy of the notice for your records. For assistance or any other questions that you may have, please contact Biomet 3i Complaints Department at 1-800-443-8166 or 1-561-776-6700. The Complaints Department is available 8:00am to 6:00pm (Eastern), Monday through Friday.

Root cause

Process control

Status

Terminated

Product code

DZE

Quantity affected

30,111 devices.

Distribution

Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain,

Date initiated

2015-09-21

Date posted

2016-01-06

Date terminated

2016-10-12

Location

Palm Beach Gardens, FL

Related 510(k) clearances