PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500
FDA device recall Z-0726-2024 · posted 2024-01-12 · Open, Classified
Recall details
- Recalling firm
- Limacorporate S.p.A
- Reason for recall
- Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
- Action taken
- On 8/29/23, the firm phoned all agents and surgeons to immediately stop surgeries with affected devices. On 10/10/23 the firm emailed recall notices to customers asking them to take the following actions: 1) Surgeons are suggested to perform a short-term patient s monitoring (radiographs at 6 weeks, 3-6 months and 1 year might be considered) and acting accordingly, based on a case-by-case evaluation. 2) Locate, quarantine, and return affected devices. Complete and return the response form to uscomplaint@limacorporate.com 3) Customers with questions can email the firm at medicalcomplaints@limacorporate.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MBF
- Quantity affected
- 179
- Distribution
- US: IL, MO, CA, IN, MI, OK
- Date initiated
- 2023-08-29
- Date posted
- 2024-01-12
- Location
- San Daniele Del Friuli, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRIMA TT Glenoid (K222427) | Lima Corporate S.P.A. | 2022-10-06 |