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Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp. Recalls

All product recalls associated with Stryker Howmedica Osteonics Corp..

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Recall Summary

Total Recalls

252

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 241–252 of 252 recalls

Stryker Howmedica Osteonics Corp.: Allocraft TLIF Bone Inserter.

Stryker was made aware that the short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.

FDAApr 4, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Osteonics Scorpio Total Knee; Posteriorly Stabilized Femo...

Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.

FDAMar 17, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: OmniFit HFx X-ray Templates, Literature No.: LTEM80 1-7; ...

The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.

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Page 13 of 13Next

FDA

Mar 9, 2005

Nationwide

• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1....

The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems.

FDAMar 9, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon Baseplate Impactor Extractor, Orthopedic manual...

Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate.

FDAFeb 23, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Posteriorly Stabilized Femoral Compone...

Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.

FDAFeb 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio Total Knee Cruciate Retraining Femoral Component;...

Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.

FDAFeb 8, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The...

Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

FDAJan 25, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And ...

The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.

FDANov 22, 2004Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: The Triathlon Posteriorly Stabilized Femoral Component.

The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.

FDAOct 27, 2004Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Long Length Dyax Nail.

Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.

FDASep 7, 2004Nationwide• Stryker Howmedica Osteonics Corp.

Howmedica Osteonics Corp.: T2 Proximal Humeral System Targeting Arm. Catalog number...

Targeting device may become distorted upon repeated autoclaving.

FDAMar 31, 2004Nationwide• Howmedica Osteonics Corp.