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Terminated

Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011

FDA Recall Z-1557-2013 · Posted 2013-06-19

Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2013-02-22
Date Terminated2015-05-21
Product Quantity10

Reason for Recall

The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3 Tubular Plate w/Collar), was released to the United States market in error. This action is not being initiated as a result of adverse events.

Firm Action

The firm initiated their recall of the product on February 22, 2013 by sending an "Urgent Notice: Medical Device Recall" letter to the firm's sales representatives. The letter requested they examine their inventory, and/or customers inventories for the Part Number and if found, return it to Synthes for appropriate disposition.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011335SYNTHS ONE-THIRD TUBULAR DCL PLATESynthes (Usa) · 2001-07-27

Official Source

View FDA Recall →

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

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