Z-1711-2016Class II

SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement

Name: Z-1711-2016 SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement
Creator: Limacorporate S.p.A
Published: 2016-04-08
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2016-04-08 / Terminated / root cause: design

FDA source

Limacorporate S.p.A began a recall of SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement on 2016-04-08. FDA classified it as Class II and gives the reason as "Complaints of intra-operative breakage of the glenosphere impactors/extractors". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1711-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Posted: 2016-05-25
Terminated: 2016-12-05
Recalling firm: Limacorporate S.p.A.
Product: SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Root cause tag: design
FDA root cause: Component design/selection
Action: The affected firms received written notification to all distributors. The letter instructed the consignee to identify and remove all affected product in stock and return parts to Lima USA.
Quantity in commerce: 314 units
Distribution: Distributed US (nationwide) and in Australia.
Product codes and lots: Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1711-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1711-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-24

Product code KWS

K110598Class IISmr Reverse Shoulder SystemLima Corporate S.P.A. / cleared 2011-08-18

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)