SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
FDA device recall Z-1317-2023 · posted 2023-04-01 · Open, Classified
Recall details
- Recalling firm
- Limacorporate S.p.A
- 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.
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- MBF
- Quantity affected
- 1
- Distribution
- US: MO
- Date initiated
- 2023-02-21
- Date posted
- 2023-04-01
- Location
- San Daniele Del Friuli, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SMR Hybrid Glenoid System (K163397) | Lima Corporate S.P.A. | 2017-06-29 |