TRIAL STEM for MP(R) RECONSTRUCTION PROTHESIS, REF 99-0143/25, Stem size 06, prox. Stem dia. 25 mm, Length 250 mm, WALDEMAR LINK GmbH & CoKG, Barkhausenweg 10 . D . 22339 Hamburg

Recall Insight

This FDA Devices action (record #Z-2073-2013) was formally reported on September 4, 2013, with the manufacturer initiating the action on July 16, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Waldemar Link GmbH & Co. KG (Corp. Hq.) is listed as the recalling firm, operating out of Hamburg. Federal records indicate 5 units units are affected.

The documented reason for this recall is: The trial stems were manufactured using the wrong design. Distribution data in the federal record shows the product reached: US Distribution to the state of Tennessee only.. 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.