Synthes

Catalog number 530.100. All lot numbers

General and Plastic Surgery Devices

1

No

The product was shipped to medical facilities and sales consultants nationwide. The product was also shipped to Canada.

Power Drive. Battery-driven power tool system intended for use during surgical procedures to provide power to operate various accessories and attachments.

Part Number 710.150.99S, Lot number N999822

General Hospital and Personal Use Devices

2

No

Nationwide Distribution-including the states of AR, CO, FL, GA, ID, LA, MA, MD, MO, MT, NY, NC, OH, SC, SD, TN, TX, and VA.

Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) || Indicated for aspirating bone marrow

Part number 01.812.001 - T-PAL Instrument and Implant Set

Orthopedic Devices

2

Yes

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, ID, IL, IN, IA, HI, KS, KY, LA, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI. and Puerto Rico and Washington, D.C; Internationally to Canada and Japan

Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. || Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

N/A - Labeling Correction

Orthopedic Devices

2

Yes

USA (nationwide) including Puerto Rico, Washington, DC and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY.

Synthes Spine Zero-P Instruments and Implants. || Zero-profile anterior cervical interbody fusion (ACIF) device.

Serial 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Radiology Devices

2

No

Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WY, WI and the countries of VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, TAIWAN, SWITZERLAND, SPAIN, SLOVENIA, SAUDI ARABIA, REPUBLIC OF KOREA, NORWAY, NEW ZEALAND, NETHERLANDS, MALTA, KUWAIT, JORDAN, JAPAN, ITALY, ISRAEL, HONG KONG, GERMANY, FRANCE, ECUADOR, DENMARK, CZECH REPUBLIC, CHINA, CHILE, CANADA, and AUSTRALIA.

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS || The Revolution XR/d with Tomosynthesis is intended for use in generating Tomographic images of human anatomy. It is not intended for mammographic use.