SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

Recall Insight

This FDA Devices action (record #Z-2540-2015) was formally reported on September 9, 2015, with the manufacturer initiating the action on August 14, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Limacorporate S.p.A is listed as the recalling firm, operating out of San Daniele Del Friuli, N/A. Federal records indicate 93 units units are affected.

The documented reason for this recall is: The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble. Distribution data in the federal record shows the product reached: US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.. 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 11 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.