Z-1261-2023Class II

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product...

Name: Z-1261-2023 TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product...
Creator: Limacorporate S.p.A
Published: 2023-01-25
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2023-01-25 / Open, Classified / root cause: manufacturing process

FDA source

Limacorporate S.p.A began a recall of TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) on 2023-01-25. FDA classified it as Class II and gives the reason as "Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1261-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-01-25
Posted: 2023-03-16
Recalling firm: Limacorporate S.p.A.
Product: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Product code: JDC Prosthesis, Elbow, Constrained, Cemented
Reason for recall: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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].
Quantity in commerce: 5 systems
Distribution: U.S. Distribution to: TX
Product codes and lots: Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1261-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1261-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-16

Product code JDC

K181362Class IITEMA Elbow SystemLima Corporate S.P.A. / cleared 2019-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)