Device Recall Malibu Polyaxial Screw

Model Number(s):  91-2109 (8.0 Plus)  91-2110 (Standard).  Lot AL549784F: 91-2109 Malibu Polyaxial Screwdriver 8.0 Plus. Lot AL552404F: 91-2110 Malibu Polyaxial Screwdriver Standard. Lot AL546768F: 91-2110 Malibu Polyaxial Screwdriver Standard.  The devices are not distributed as sterile and do not have a expiration date.

Orthopedic Devices

2

Yes

Worldwide Distribution - USA including IA, FL, LA, IL, CA, TX, AZ, NC, MD, NM, VA, and Internationally to South Africa.

Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109; || Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110. || 510(k): || 91-2109 K061342. || 91-2110 K051942. || The Malibu" System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The System is comprised of single use pedicle screws of varying reduction height, rods, rod connectors, etc. and an accompanying set of reusable surgical instruments. Some of the surgical instruments are specific to the system and others are general surgical instruments. The polyaxial screwdriver is specific to the polyaxial screws in the system.

Lot Number: A1762B

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.

Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535 || Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Lot Number: A1724A

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.

Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550 || Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Lot Numbers: A1890A and A1893A

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.

Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530 || Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

Lot Number: A1749B

Orthopedic Devices

2

Yes

Worldwide Distribution -- USA, including states of AL, AZ, CA, CO, FL, GA, IN, MD, MI, MO, MS, NM, OK, TN, TX, VA, and WI and country of Greece.

Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535 || Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.