FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- Recall number
- Z-1261-2023
- 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)
- Status
- Open, Classified
- Initiated
- 2023-01-25
- Posted
- 2023-03-16
- Terminated
- not on file
- Reason
- Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- 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 medicalcomplaints@limacorporate.com.
- Quantity
- 5 systems
- Distribution
- U.S. Distribution to: TX
- Lot, serial or model codes
- Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
- 510(k) numbers
- K181362
- PMA numbers
- not on file
- Product code
- JDC
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28