SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
This recall is currently active, issued April 1, 2023. It was issued by Limacorporate S.P.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy.
- Recall Initiated
- February 21, 2023
- Posted
- April 1, 2023
- Recall Number
- Z-1317-2023
- Quantity
- 1
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US: MO
Lot / Code Info
UDI-DI/Lot/Expiration: 08033390121798/2206565/2027-04-30
Root Cause
Process control
Action Taken
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