FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
- Recall number
- Z-1711-2016
- Recalling firm
- Limacorporate S.p.A
- Product
- SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
- Status
- Terminated
- Initiated
- 2016-04-08
- Posted
- not on file
- Terminated
- 2016-12-05
- Reason
- Complaints of intra-operative breakage of the glenosphere impactors/extractors.
- 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
- 314 units
- Distribution
- Distributed US (nationwide) and in Australia.
- Lot, serial or model codes
- Lot numbers: 1390763, 14AA094, 14AA431, 14AA528, 15AA094, 15AA557, 15AA558, 15AA559, 15AA600
- 510(k) numbers
- ["K110598"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28