Optetrak Logic Comprehensive Knee Prosthesis System recall
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Why was Optetrak Logic Comprehensive Knee Prosthesis System recalled?
A dimensional mismatch was identified which can potentially allow for interference between devices.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog # 02-012-42-3508 All lot numbers
- Product
- Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
- Recalling firm
- Exactech, Inc.
- Quantity
- 123 devices
- Distribution
- Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
- Recall date
- March 27, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)