The 45mm Left Standard Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to f

FDA device recall Z-0822-2012 · posted 2012-01-20 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.

Action taken

Biomet Microfixation Inc sent an URGENT-Medical Device Recall notice to all consignees. The letter informs the customers to discontinue use of the items and return them to Biomet Microfixation.They also ask all customers to complete the inventory reconciliation sheet and return it by fax to the Global Complaint Coordinator. The letter also states that if the product was further distributed, the letter must be forwarded on to the firm's customers. For questions call 1-800-874-7711 or 904-741-4400, ext 468.

Root cause

Employee error

Status

Terminated

Product code

MPL

Quantity affected

2 pieces

Distribution

Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala.

Date initiated

2010-04-07

Date posted

2012-01-20

Date terminated

2012-02-06

Location

Jacksonville, FL