All distributed lots and serial numbers

Orthopedic Devices

2

Yes

Nationwide Distribution-including the states of IL, MN, NV, OK, and TX.

Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). || The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities: 1 - degenerative disc disease, 2 - spondylolisthesis, 3 - trauma, 4 - spinal stenosis, 5 - deformities or curvatures, 6 - tumor, 7 - pseudoarthrosis, and 8 - failed previous fusion.

Part no. SN038P, batch number 51915765

Orthopedic Devices

2

Yes

US Distribution including the states of NV and MI

ProSpace Peek Implant 5 degree x 8.5 x 22 mm || The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

lots: 51468773, 51447588, 51468302, 51503760, 51571394, 51585136, 51447597

Orthopedic Devices

2

Yes

Distributed in FL and MD.

Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7

All Lot Numbers

Orthopedic Devices

2

Yes

Nationwide-USA including states of AZ, GA, MD, OK, PA, TX, and VA (distributors) medical facilities in FL, NY, and PA; and sales representatives in CA and FL.

Excia Cemented Hip Stems ,Size 18mm, Part Number NJ318K, Aesculap Implant Systems, Inc., Center Valley, PA 18034