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

Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.

FDA Recall Z-0406-2014 · Posted 2013-11-27

Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-07-30
Date Terminated2015-08-17
Product Quantity13

Reason for Recall

A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.

Firm Action

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K001941SYNTHES MODULAR FOOT SYSTEMSynthes (Usa) · 2000-09-22

Official Source

View FDA Recall →

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

↑