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Wright Medical Technology, Inc.

Wright Medical Technology, Inc. Recalls

All product recalls associated with Wright Medical Technology, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2024

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 21–40 of 47 recalls

Wright Medical Technology, Inc.: WRIGHT EVOLVE Proline Head, Size: +2, OD: 20mm, REF 496H220

Two lots of EVOLVE Modular Radial Head could have the wrong size product in the package. Both the label and laser marking are incorrect on the affected product.

FDADec 27, 2019Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 4024...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE,...

Plates manufactured from an incorrect raw material.

Class II

123

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Moderate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm,...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 4024...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 4024...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm,...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 4024...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology, Inc.: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 25mm,...

Plates manufactured from an incorrect raw material.

Class IIModerate

FDAJul 30, 2014Nationwide• Wright Medical Technology, Inc.

Wright Medical Technology Inc: ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEF...

The left medial pivot and right medial pivot inserts were co-mingled

FDANov 24, 2009Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIG...

The left medial pivot and right medial pivot inserts were co-mingled

FDANov 24, 2009Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140...

Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.

FDASep 22, 2009Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140...

FDASep 22, 2009Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, ...

Incorrect packaging, swapped sizes

FDAMay 14, 2009CA, FL, IN +10 more• Wright Medical Technology Inc

Wright Medical Technology Inc: Screwdriver for 3.5mm Screws, DARCO system, instrument fo...

The package insert lists 3 sterilization procedures, 2 of which are not validated. Pre-vacuum steam sterilization is validated.

FDAFeb 19, 2009Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 68mm OD, Group H, REF 3300-GH68, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only,...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 66mm OD, Group H, REF 3300-GH66, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc

Wright Medical Technology Inc: Dynasty Trial Shell 64mm OD, Group H, REF 3300-GH64, Rx o...

Trials are 2.5mm larger than marked.

FDAMay 20, 2008Nationwide• Wright Medical Technology Inc