Z-2850-2011

"REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KITSTERILE PRODUCTSTERILE EOKIT CONTAINS BOTH...

Name: Z-2850-2011 "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH...
Creator: Biomet Microfixation, Inc.
Published: 2010-10-08
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-10-08 / Terminated

FDA source

Biomet Microfixation, Inc. began a recall of "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by... on 2010-10-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2850-2011
Status: Terminated
Initiated: 2010-10-08
Posted: 2011-07-19
Terminated: 2012-04-19
Recalling firm: Biomet Microfixation
Product: "***REF: 24-3050 TMJ SYSTEM OnPoint SCOPE PROCEDURE KIT***STERILE PRODUCT***STERILE EO***KIT CONTAINS BOTH STERILE AND NON-STERILE COMPONENTS Distributed by: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***" Kit Contains: Drape with pouch; 22g1.5in needle; OR towel; Towel clips; Skin marker with rule; Band-aids; Syringe pump tubing set; Cotton ball; 60ml syringe; Facial ice pack; Extension tubing; Chloraprep Swabsticks. All-inclusive kit that alleviates the burden of piecing together each of the items necessary for a Arthroscopy using the OnPoint Scope.
Product code: KDD Kit, Surgical Instrument, Disposable
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.
FDA root cause: Pending
Action: 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.
Quantity in commerce: 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, TX, UT, VA and WA; and countries of: Argentina, Bahrain, Canada, Colombia, Costa Rica, and Finland.
Product codes and lots: All lots prior to 09/14/2010 for Model Number 24-3050.

Product code KDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)