Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0393-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Synthes Material Mix (Adjustable Cervical Distractor-Right, Matrix Distractor Rack, T-PAL Spacer Remover, Implant Inserter) Synthes Material Mix: Adjustable Cervical Distractor-Right is used to distract spine segment. Matrix Distractor Rack is used to distract the interbody disc space. T-PAL Spacer Remover is used to remove T-PAL spacer. Implant Inserter is used to insert the ProDisc implant.

Product Classification:

Class II

Date Initiated: October 15, 2013

Date Posted: December 4, 2013

Recall Number: Z-0393-2014

Event ID: 66551

Reason for Recall:

One material batch used for production of the affected parts of the Synthes Material Mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

Status: Terminated

Product Quantity: approximately 44

Code Information:

part no. 396.396 (lot nos. T989765 and T989780), part no. 03.632.087 (lotT987270), part no. 03.812.005 (lot nos. T987734, T988931, and T987623), and part no. 03.820.129 (lot no. T988206).

Distribution Pattern:

Worldwided Distribution: USA (nationwide) including IL, MO, TX, WA and Internationally to Canada and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated