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Lower risk Medical device recall · FDA · Published September 19, 2017

Exactech Optetrak Constrained Condyl: Design Incompatibility Risk

Exactech recalls Optetrak Constrained Condylar Offset Screw Size AA (Ref 208-04-70) due to design incompatibility with certain tibial inserts, potentially causing improper joint function.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0146-2018Medical deviceExactech ›
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Recalling firmExactech, Inc.2320 NW 66th Ct · Gainesville, FL 32653-1630
✎ GovInfoNow plain-language explainer

What happened, in plain English

Exactech is recalling a specific type of knee implant screw because it may not fit correctly with some joint components, which could lead to improper joint function. This affects patients who received this exact screw model during surgery. Read more at govinfonow.com/recall/72973-exactech-optetrak-constrained-condyl-design-incompatibility-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/72973-exactech-optetrak-constrained-condyl-design-incompatibility-risk · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0146-2018

Cite this page

“Exactech Optetrak Constrained Condyl: Design Incompatibility Risk.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72973-exactech-optetrak-constrained-condyl-design-incompatibility-risk. Based on FDA recall #Z-0146-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0146-2018%22&limit=1).

Why it’s dangerous

The screw design may not properly align with certain tibial inserts when used with an offset tibial tray, potentially causing improper joint function. This incompatibility could lead to complications during knee replacement surgery.

Who’s affected

Patients who received the Optetrak Constrained Condylar Offset Screw, Size AA (Ref 208-04-70) during surgery are most at risk. This recall applies to all units sold with the specific lot numbers.

How to tell if you have this one

Check if your knee implant includes the Optetrak Constrained Condylar Offset Screw, Size AA (Ref 208-04-70) with sterile packaging. This product was sold with all lot numbers.

  • Brand
    Exactech
  • Category
    Medical device
FDA recall event · 34 products

All 34 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • 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.
Recall numberProduct, codes & lotsQuantity
Z-0126-2018Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.; All lot numbers57 devices
Z-0127-2018Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.; All lot numbers109 devices
Z-0128-2018Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.; All lot numbers114 devices
Z-0129-2018Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.; All lot numbers198 devices
Z-0130-2018Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.; All lot numbers207 devices
Z-0131-2018Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.; All lot numbers640 devices
Z-0132-2018Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.; All lot numbers665 devices
Z-0133-2018Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.; All lot numbers801 devices
Z-0134-2018Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.; All lot numbers893 devices
Z-0135-2018Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.; All lot numbers733 devices
Z-0136-2018Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.; All lot numbers683 devices
Z-0137-2018Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.; All lot numbers720 devices
Z-0138-2018Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.; All lot numbers527 devices
Z-0139-2018Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.; All lot numbers573 devices
Z-0140-2018Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.; All lot numbers547 devices
Z-0141-2018Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .; All lot numbers537 devices
Z-0142-2018Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.; All lot numbers311 devices
Z-0143-2018Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.; All lot numbers333 devices
Z-0144-2018Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.; All lot numbers317 devices
Z-0145-2018Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.; All lot numbers306 devices
Z-0146-2018Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .; All lot numbers643 devices
Z-0147-2018Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.; All lot numbers840 devices
Z-0148-2018Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.; All lot numbers889 devices
Z-0149-2018Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.; All lot numbers920 devices
Z-0150-2018Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.; All lot numbers953 devices
Z-0151-2018Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.; All lot numbers895 devices
Z-0152-2018Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.; All lot numbers606 devices
Z-0153-2018Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.; All lot numbers656 devices
Z-0154-2018Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.; All lot numbers575 devices
Z-0155-2018Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.; All lot numbers537 devices
Z-0156-2018Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.; All lot numbers520 devices
Z-0157-2018Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.; All lot numbers386 devices
Z-0158-2018Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.; All lot numbers411 devices
Z-0159-2018Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.; All lot numbers678 devices
Based on the official FDA remedy

What to do — step by step

  1. Check Your Implant Details

    Review your surgical records to confirm if you received the Optetrak Constrained Condylar Offset Screw, Size AA (Ref 208-04-70).

Where it went and when

Where it was distributed

Distributed in 10 states and Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: yesMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: yesNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: yesFLPuerto Rico: yesPR

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Puerto Rico, Virginia.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

1. Firm started the recall: Sep 19, 201712. FDA classified it Class II: Nov 20, 201723. Published in FDA’s Enforcement Report: Nov 29, 201734. FDA terminated the recall: Jun 21, 2021420172021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0146-2018 (September 19, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0146-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA