FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- Recall number
- Z-1317-2023
- Recalling firm
- Limacorporate S.p.A
- Product
- SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
- Status
- Open, Classified
- Initiated
- 2023-02-21
- Posted
- 2023-04-01
- Terminated
- not on file
- Reason
- Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
- Root cause
- Process control
- Action
- On 2/21/23, a recall notice was distributed to a customer who was asked to do the following: 1) Check your stock to locate and quarantine the affected devices. Devices must be sent back. 2) Complete, and return the response form to pms@limacorporate.com 3) The recall notice should be shared with anyone who needs to be aware within your organization or shared with any organization where the potentially affected products have been transferred. Inquiries can be sent to medicalcomplaints@limacorporate.com
- Quantity
- 1
- Distribution
- US: MO
- Lot, serial or model codes
- UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
- 510(k) numbers
- ["K163397"]
- PMA numbers
- not on file
- Product code
- MBF
- 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