Novation recallZ-1030-2017 · Exactech, Inc. · initiated Nov 7, 2016
Terminated
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
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
FDA root cause category: Under Investigation by firm
What the company is doing
In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at [email protected] or 1-800-392-2832.
Recall details
- Recall number
- Z-1030-2017
- Status
- Terminated
- Initiated by the company
- Nov 7, 2016
- Recalling firm
- Exactech, Inc.
- Quantity
- 79 units
- Product code
- JDI
- FDA submissions
- K083392
- Distribution
- AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
Product description
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Code information (models, lots, serial numbers)
Serial No. 4110119-4110122, 4120841-4120848, 412748, 4159075-4159082, 4175043-4175054, 4224284-4224299, 4384453-4384471, 4534398-4534399, 4565752-4565760; Catalog No. 160-70-15; UDI: 10885862033086
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Novation 160-70-15Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented1 recall1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 75989).
- Z-1031-2017 · TerminatedAcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
- Z-1032-2017 · TerminatedAlteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
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 16, 2026. Text above is shown as published by the FDA.
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