Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Reported: November 29, 2017 Initiated: September 19, 2017 #Z-0132-2018
Product Description
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Reason for Recall
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.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 665 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.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.. Recalled by Exactech, Inc.. Units affected: 665 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0132-2018.
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