Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-1711-2016 · Posted None

Recalling FirmLimacorporate S.p.A
Recall StatusTerminated
Product CodeKWS
Date Initiated2016-04-08
Date Terminated2016-12-05
Product Quantity314 units

Reason for Recall

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

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Distributed US (nationwide) and in Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110598SMR REVERSE SHOULDER SYSTEMLima Corporate S.P.A. · 2011-08-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑