Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

Recall Insight

This FDA Devices action (record #Z-1526-2018) was formally reported on May 2, 2018, with the manufacturer initiating the action on March 12, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker GmbH is listed as the recalling firm, operating out of Selzach, N/A. Federal records indicate 18 units are affected.

The documented reason for this recall is: The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling Distribution data in the federal record shows the product reached: USA (nationwide) Distribution. 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 8 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.