Limacorporate S.p.A: Medical Device Recall in 2015 - (Recall #: Z-2539-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

Product Classification:

Class II

Date Initiated: August 14, 2015

Date Posted: September 9, 2015

Recall Number: Z-2539-2015

Event ID: 71972

Reason for Recall:

The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.

Status: Terminated

Product Quantity: 110 units

Code Information:

Lot Numbers: 14AA234, 14AA235, 14AA233

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated