RecallRadar

FDA Device recall Z-1711-2016

SMR glenosphere impactor/extractor

On 2016-06-01 the FDA classified a Class II recall of SMR glenosphere impactor/extractor by Limacorporate S P A, citing complaints of intra-operative breakage of the glenosphere impactors/extractors.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1711-2016
ClassificationClass II
Statusterminated
Initiated2016-04-08
Published2016-06-01
Last updated2026-09-13 11:54 UTC
CompanyLimacorporate S P A
DistributionUS

Product

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

Reason

Complaints of intra-operative breakage of the glenosphere impactors/extractors.

Identifiers

code_infoLot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1711-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.