Device Recall TPS

122518, 122447.

Orthopedic Devices

1

No

Nationwide Distribution.

TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. || Orthopedic manual surgical instrument

Serial Number 0214200753

Ear, Nose, and Throat Devices

2

No

Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

Stryker TPS Universal Driver REF 5100- 99 Rx , || The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices.

All lots.

Neurological Devices

2

No

Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

Stryker Instruments 7.0mm Round Fluted Bur Extra Long, for use with TPS Universal Drill Extra Long "R" attachment, sterile, Stryker Instruments, Kalamazoo, MI; REF 5260-10-70.

All lots.

Neurological Devices

2

No

Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

Stryker 9.1mm x 7.9mm XX Coarse Diamond Drum, Super Long, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-21-991.

All lots.

Neurological Devices

2

No

Worldwide Distribution - USA, Australia, Brazil, Canada, England, France, Germany, Hong Kong, India, Italy, Japan, Mexico, the Netherlands, New Zealand, Portugal, Saudi Arabia, Poland, Romania, South Africa, Spain, Sweden, Switzerland and United Arab Emirates.

Stryker 3.1mm x 19.1mm Straight Router, sterile, Stryker Instruments, Kalamazoo, MI; REF 5190-70-31.