TEMA Elbow recallZ-1261-2023 · Limacorporate S.p.A · initiated Jan 25, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Limacorporate S.p.A or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
FDA root cause category: Employee error
What the company is doing
On or about 01/25/2023, the firm sent a "VOLUNTARY CORRECTION" Letter via email to customers informing them that the firm has become aware that it incorrectly included low constraint Tema axle small components (not cleared for marketing in U.S.) with its high constraint humeral bodies system. According to the firm's records, 3 low constraint components were implanted between 12/10/2021 to 07/05/2022. Customers are being instructed to: LimaCorporate suggests to Surgeons and Hospitals where an affected device listed in Table 1 was implanted in combination with high constraint humeral bodies components belonging to the product family 1550.15.0XX to yearly follow-up patients with radiographs and varus/valgus range-of-motion evaluation to assess for poly bushing wear. If the follow-up monitoring after 24 months from the implant date shows uneventful and no abnormality, surgeons are invited to do patient follow-up according to the standard protocols, except in case of pain subsequently experienced by the patient. In addition, customers will be instructed by the firm's U.S Regulatory Affairs Associate to post the letter in or near implanted patients' records to continuously remind surgeons and hospitals to monitor their implant patients regarding this Voluntary Correction. For questions or further assistance, contact the firm via email at [email protected].
Recall details
- Recall number
- Z-1261-2023
- Status
- Open, Classified
- Initiated by the company
- Jan 25, 2023
- Posted by the FDA
- Mar 16, 2023
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 5 systems
- Product code
- JDC
- FDA submissions
- K181362
- Distribution
- U.S. Distribution to: TX
Product description
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Code information (models, lots, serial numbers)
Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TEMA Elbow 1590.15.010Limacorporate SPA · Prosthesis, Elbow, Semi-Constrained, Cemented2 recalls3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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