Optetrak Constrained Condylar Offset Screw recall
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
Why was Optetrak Constrained Condylar Offset Screw recalled?
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
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?
All lot numbers
- Product
- Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
- Recalling firm
- Exactech, Inc.
- Quantity
- 840 devices
- Distribution
- Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)