FDA Device recall Z-0147-2018
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX
- FDA Device
- Class II
- terminated
- Published 2017-11-29
On 2017-11-29 the FDA classified a Class II recall of Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX by Exactech, citing 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 tibi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0147-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-09-19 |
| Published | 2017-11-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Exactech |
| Distribution | AL, FL, IN, ME, MN, NJ, NY, OH, OK, PR, VA |
Product
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
Reason
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.
Identifiers
| code_info | All lot numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0147-2018%22
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