Class 2 Device Recall TEMA Axle Small

• Date Initiated by Firm: January 25, 2023
• Date Posted: March 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1261-2023
• Recall Event ID: 91613
• 510(K)Number: K181362
• Product Classification: Prosthesis, elbow, constrained, cemented - Product Code JDC
• Product: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
• Code Information: Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241
• Recalling Firm/ Manufacturer: Limacorporate S.p.A; Via Nazionale 52; Di San Daniele; San Daniele Del Friuli Italy
• For Additional Information Contact: Mr. Roberto Gabetta ; +390432945511
• Manufacturer 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.
• FDA Determined 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 in Commerce: 5 systems
• Distribution: U.S. Distribution to: TX
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JDC