Synthes, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1681-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

Synthes XRL Medium Trial - Central Body, an instrument used as part of the Synthes XRL System, a vertebral body replacement device. For spinal surgery. The Synthes XRL device is intended to be used with the Synthes supplemental internal fixation systems (e.g., USS, including MATRIX, Pangea, and TSLP).

Product Classification:

Class II

Date Initiated: April 8, 2014

Date Posted: June 11, 2014

Recall Number: Z-1681-2014

Event ID: 68006

Reason for Recall:

Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height.

Status: Terminated

Product Quantity: 3

Code Information:

Product no. 03.807.507, lot no. 8029684, and product no. 03.807.508, lot no. 8029689.

Distribution Pattern:

US Distribution including the states of FL, NJ and MN.

Voluntary or Mandated:

Voluntary: Firm initiated