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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Exactech, Inc.: 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.

Agency Publication Date: November 20, 2017
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Affected Products

Product: Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .

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Product: Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .

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Product: Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.

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Product: Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.

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Product: Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.

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Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78111
Status: Resolved
Manufacturer: Exactech, Inc.
Manufactured In: United States
Units Affected: 34 products (57 devices; 109 devices; 114 devices; 198 devices; 207 devices; 640 devices; 665 devices; 801 devices; 893 devices; 733 devices; 683 devices; 720 devices; 527 devices; 573 devices; 547 devices; 537 devices; 311 devices; 333 devices; 317 devices; 306 devices; 643 devices; 840 devices; 889 devices; 920 devices; 953 devices; 895 devices; 606 devices; 656 devices; 575 devices; 537 devices; 520 devices; 386 devices; 411 devices; 678 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.