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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

180

Past Year

Class I (Serious)

Most Recent

Dec 2014

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 1–20 of 180 recalls

Stryker Howmedica Osteonics Corp.: Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug ...

Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

Class IIModerate

FDADec 15, 2014Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics RESTORATION Acetabular Augmen...

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Class IIModerate

FDAAug 15, 2014Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Triathlon femoral component. Howmed...

12 3...9

Page 1 of 9Next

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Class IIModerate

FDAAug 15, 2014Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Scorpio femoral component. Howmedic...

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Class IIModerate

FDAAug 15, 2014Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, S...

Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package label.

Class IIModerate

FDAJul 24, 2014Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Howmedica Osteonics Corp. Restoration Modular Revision Hi...

The Restoration Modular Hip Stem may have two different package labels. The 14 mm diameter stem may be labeled with both a size 14 mm diameter and a 26 mm diameter.

FDADec 30, 2009GA, IN• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker T2 Ankle Arthrodesis Nail, left; 011 x 300 mm; Ca...

Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.

FDADec 29, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker T2 Ankle Arthrodesis Nail, left; 010 x 300 mm; C...

Stryker Orthopaedics became aware that there is the potential for damage to the sterile packaging of the product during transport.

FDADec 29, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, C...

The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.

FDADec 22, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon Total Stabilizer Femoral Component; Size # 2 f...

Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.

FDADec 10, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon Total Stabilizer Femoral Component; For Use wit...

Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.

FDADec 10, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block S...

Laceration Risk

The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

FDADec 3, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 4; X...

Laceration Risk

The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

FDADec 3, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block X...

Laceration Risk

The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

FDADec 3, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics, Scorpio Ceramic 4:1 Guide Size 3; X...

Laceration Risk

The ceramic guide rails, within the XCelerate 4:1 Ceramic Cutting Blocks, may fracture and displace from the block.

FDADec 3, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Orthopaedics Sterile Knee Instrument, Patella Cut...

Laceration Risk

Disposable Patella Cutters - 30 mm (catalog number 8000-0030, lot V31257001) were packaged and labeled as 33 mm Disposable Patella Cutters (catalog number 8000-0033, lot V31257001 and vice versa.

FDANov 11, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio NRG Posterior Stabilized Femoral. # 4 left/right;...

It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.

FDAOct 2, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio CR Waffle Femur Lfit with posts; Stryker Orthopae...

FDAOct 2, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio NRG Posterior Stabilized Femoral, #3 Left; Stryke...

FDAOct 2, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Scorpio NRG Cruciate Retaining Femoral, Right # 7; Stryke...

FDAOct 2, 2009Nationwide• Stryker Howmedica Osteonics Corp.