Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

FDA Recall Z-0524-2024 · Posted 2023-12-09

Recalling FirmLimacorporate S.p.A
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-10-27
Product Quantity33 devices

Reason for Recall

Due to incorrect product labeling

Firm Action

On 10/27/2023, the firm sent via email an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm was made aware of a mistake on the label of the HPS tibial liner #6H. 10mm. Customers are instructed to: Check their stock to locate and quarantine the affected devices. Devices must be sent back to the Lima local reference within 15 days together with a hard copy of the attached Acknowledgement and Receipt Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA For questions or further assistance, email [email protected].

Root Cause

Labeling Change Control

Distribution Pattern

U.S Distribution: AZ, CA, IL, LA, and NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K213381Physica systemLima Corporate S.P.A. · 2021-12-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑