"***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND N

FDA device recall Z-2850-2011 · posted 2011-07-19 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.

Action taken

Biomet Microfixation (formerly W. Lorenz) sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter to the consignees/customers on October 7, 2010. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to fill out the attached Inventory Reconciliation sheet and fax to 904-741-9425 and if the consignees/customers further distributed this product, they should notify their customers and provide them with a copy of this safety alert (the letter must be given to the personnel responsible for receiving field action notices). If you have any questions, please contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.

Root cause

Pending

Status

Terminated

Product code

KDD

Quantity affected

607

Distribution

Worldwide distribution: USA (nationwide) including states of: AL, AR, CA, CO, CT, DC, CR FL,GA, HI, IA, IL, IN, KS, KY, LA, MA, MD,ME, MI MN, MO, MS, MT, NC, ND, NJ, NY, OH, O K, OR, PA, RI, SC, TN, T

Date initiated

2010-10-08

Date posted

2011-07-19

Date terminated

2012-04-19

Location

Jacksonville, FL