Exactech Optetrak Logic CC 15mm Tibial Augment Screws recallZ-2704-2017 · Exactech, Inc. · initiated Apr 7, 2017
Class II Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
FDA root cause category: Process control
What the company is doing
Consignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at [email protected] or 800-392-2832.
Recall details
- Recall number
- Z-2704-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 7, 2017
- Posted by the FDA
- Jun 19, 2017
- Recalling firm
- Exactech, Inc.
- Quantity
- 9 devices
- Product code
- JWH
- FDA submissions
- K150890
- Distribution
- CA and NY.
Product description
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Code information (models, lots, serial numbers)
Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.
Other devices under the same FDA submission
71 devices cleared under K150890 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Optetrak Logic 02-012-65-4011Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak Logic 02-012-65-3011Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak Logic 02-012-65-4017Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall3 reports
- Optetrak Logic 02-012-65-1009Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-2013Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-2015Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-2021Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-3015Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-4013Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-4015Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-5017Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak Logic 02-012-65-1021Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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