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).

Recall Insight

This FDA Devices action (record #Z-1681-2014) was formally reported on June 11, 2014, with the manufacturer initiating the action on April 8, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records indicate 3 units are affected.

The documented reason for this recall is: Two lots of the Synthes XRL Medium Trial-Central Body device were incorrectly etched with the incorrect dimensions for height. Distribution data in the federal record shows the product reached: US Distribution including the states of FL, NJ and MN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.