Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.

Recall Insight

This FDA Devices action (record #Z-0341-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on September 24, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes USA HQ, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records indicate 374 units are affected.

The documented reason for this recall is: The potential exists for the locking screw nut to break on the Soft Tissue Retractor if it is overt-tightened. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (Nationwide) and Canada.. 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 13 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.