Z-2539-2015Class II

SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral...

Name: Z-2539-2015 SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral...
Creator: Limacorporate S.p.A
Published: 2015-08-14
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2015-08-14 / Terminated / root cause: manufacturing process

FDA source

Limacorporate S.p.A began a recall of 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... on 2015-08-14. FDA classified it as Class II and gives the reason as "The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2539-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-14
Posted: 2015-09-02
Terminated: 2016-02-26
Recalling firm: Limacorporate S.p.A.
Product: 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 code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 110 units
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 codes and lots: Lot Numbers: 14AA234, 14AA235, 14AA233

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2539-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2539-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02
Z-2540-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-02

Product code KWT

K100858Class IILima-Lio Smr Shoulder System - Humeral Stems, Lima-Lio Smr Shoulder System - Humeral Bodies,Lima-Lto S.P.A. / cleared 2010-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)