Exact FDA event identifier

Event 71972

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 14, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Limacorporate S.p.A

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2539-2015

Recall number: Z-2539-2015
Initiated: August 14, 2015
Classification: Class II
Status: Terminated
Recalling firm: Limacorporate S.p.A
Quantity: 110 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 2 of 2

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.

Z-2540-2015

Recall number: Z-2540-2015
Initiated: August 14, 2015
Classification: Class II
Status: Terminated
Recalling firm: Limacorporate S.p.A
Quantity: 93 units