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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 121–140 of 180 recalls

Stryker Howmedica Osteonics Corp.: ReUnion Fracture Stem Humeral Component - PureFix HA; Sho...

The plasma spray may delaminate from the proximal portion of the humeral stem.

FDAMay 9, 2007IN, OH• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numb...

Laceration Risk

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

FDAFeb 12, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon AR 4:1 Cutting Blocks - Size 1-8; Catalog Numbe...

Laceration Risk

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

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FDAFeb 12, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Holding Forceps for Trident Acetabular System; non Steril...

The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.

FDAJan 24, 2007Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon X3 CR Tibial Bearing Insert Size #7 - 11MM Ref ...

A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.

FDADec 4, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon X3 CR Tibial Bearing Insert for knee prosthesis...

A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa.

FDADec 4, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Howmedica Hip Fracture Stem System, Product Number: 6942-...

Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.

FDANov 28, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: T2 Ankle Arthrodesis Nail Surgical Protocol, Catalog Numb...

Operative Surgical Technique was found to have a typographical error where hyphens were inadvertently omitted in incision lengths (i.e. 1520 cm should be 15-20 cm).

FDANov 17, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Simplex P with Tobramycin. Antibiotic PMMA Bone Cement.

The expiration date on the external label is incorrect in that it does not identify the earliest expiration date of the subcomponents. The External label provides for an incorrect longer expiration date than the actual subcomponents will support.

FDANov 7, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Duracon Total Knee Modular Femoral Component; Non-Porous ...

Loose fixation pegs: One lot of femoral components may have loose fixation pegs.

FDAOct 17, 2006GA, IN• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Duracon Total Knee Distal Femoral Locking Screw for 5 mm ...

Stryker Orthopaedics became aware that a box labeled as Duracon Total Knee Distal Femoral Locking Screws for 5 mm spacer, may actually contain a 10 mm screw.

FDAOct 5, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon Total Knee system Primary Tibial Baseplate #5 B...

Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating.

FDASep 21, 2006AL, GA, OR +3 more• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon MIS Modular Capture;Catalog Number: 6541-5-723;...

Assembly problems: MIS instruments (Triathlon MIS AP Sizer Body - Left; Triathlon MIS Sizer Body - Right; Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture) may not assemble properly.

FDASep 19, 2006IL, MI• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon MIS Femoral Adjustment Block;Catalog Number: 65...

FDASep 19, 2006IL, MI• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Triathlon MIS AP Sizer Body - Left and Right; Catalog Nu...

FDASep 19, 2006IL, MI• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker...

The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.

FDAAug 2, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: S T-Bone Plate; M T-Compression Plate; Manufactured and D...

A package labeled as a S T-Bone Plate, Catalog Number 57-05260, Lot Code G4M00F1576, may actually contain a M T-Compression Plate, Catalog Number 57-10250, Lot Code G4N00F1584 and vice versa.

FDAMay 26, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Steril...

A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.

FDAMay 5, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Lateral Decubitus Alignment Guide, Non Sterile; manual su...

The Lateral Decubitus Alignment Guide either did not assemble to its mating part, the Curved Impaction Handle, or partially engages the handle, but does not fully lock.

FDAApr 27, 2006Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Trident PSL Acetabular Shell;Arc Deposited;Hydroxylapatit...

Dimensional anomaly

FDAMar 13, 2006Nationwide• Stryker Howmedica Osteonics Corp.