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.

Terminated

LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465

FDA Recall Z-0489-2007 · Posted 2007-01-11

Recalling FirmSynthes
Recall StatusTerminated
Product CodeHRS
Date Initiated2006-12-05
Date Terminated2007-02-13
Product Quantity11 units

Reason for Recall

Hole is malformed, leading to reduced construct strength.

Firm Action

All Sales Consultants were notified of the recall via teleconference on 12/5/06. The telephone script, part number and affected lot were communicated to the consultants during the teleconference. They were instructed to retrieve the affected product from the field.

Root Cause

Other

Distribution Pattern

The products were shipped to medical facilities in NJ, TN, LA, and KS. The products were also shipped to sales reps in PA, SC, and CA. The product was also shipped to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012114SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEMSynthes (Usa) · 2001-09-28

Official Source

View FDA Recall →

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

↑