TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

FDA device recall Z-1261-2023 · posted 2023-03-16 · Open, Classified

Recall details

Recalling firm

Limacorporate S.p.A

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.

Action taken

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.

Root cause

Employee error

Status

Open, Classified

Product code

JDC

Quantity affected

5 systems

Distribution

U.S. Distribution to: TX

Date initiated

2023-01-25

Date posted

2023-03-16

Location

San Daniele Del Friuli, Italy

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