djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair

Recall Insight

This FDA Devices action (record #Z-2146-2012) was formally reported on August 15, 2012, with the manufacturer initiating the action on July 16, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Encore Medical, Lp is listed as the recalling firm, operating out of Austin, TX. Federal records indicate 18 devices units are affected.

The documented reason for this recall is: One lot of the 010-55-030, 6.5 mm Cancellous Bone Screw was recalled because a product complaint identified a mislabeling of the device. Although the package label indicates Size 30mm, the screw dimension is actually 2… Distribution data in the federal record shows the product reached: Nationwide Distribution including AR, CA, FL, ID, OK, PA, TX, and UT.. 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 14 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.