Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

Recall Insight

This FDA Devices action (record #Z-2038-2020) was formally reported on May 27, 2020, with the manufacturer initiating the action on April 3, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Pega Medical Inc. is listed as the recalling firm, operating out of Laval, N/A. Federal records indicate 3 units units are affected.

The documented reason for this recall is: The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. Distribution data in the federal record shows the product reached: US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.. 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 6 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.