SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF… recallZ-2540-2015 · Limacorporate S.p.A · initiated Aug 14, 2015
Class II Terminated All recalls posted in September 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Lima Corporate sent an Urgent Attention Recall letter on August 11, 2015, to US distributors and Sales Agents. The affected customers were instructed to examine their inventory, return the affected lots to the recalling firm, and complete a response form.
Recall details
- Recall number
- Z-2540-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 14, 2015
- Posted by the FDA
- Sep 2, 2015
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 93 units
- Product code
- HSD
- FDA submissions
- K100858
- Distribution
- 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.
Product description
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.
Code information (models, lots, serial numbers)
Lot Numbers: 14AA146 and 14AA153
Other devices under the same FDA submission
26 devices cleared under K100858 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SMR Shoulder Humeral HeadLimacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented6 reports
- SMR Shoulder Humeral HeadLimacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented4 reports
- SMR System 1322.09.440Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented4 reports
- SMR Shoulder Humeral HeadLimacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR Shoulder Expansion ExtractorLimacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR Shoulder 9013.52.147Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR System 1322.09.460Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR System 1322.09.480Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR System 1322.09.520Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented3 reports
- SMR Shoulder Humeral HeadLimacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- SMR System 1322.09.500Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- SMR System 1322.09.540Limacorporate SPA · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 71972).
- Z-2539-2015 · TerminatedSMR 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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