Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar… recallZ-1557-2013 · Synthes USA HQ, Inc. · initiated Feb 22, 2013
Class II Terminated All recalls posted in June 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1557-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 22, 2013
- Posted by the FDA
- Jun 19, 2013
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 10
- Product code
- HRS
- FDA submissions
- K011335
- Distribution
- Nationwide distribution.
Product description
Synthes 11-Hole, 1/3 Tubular Plate DCL Plate with Collar, Part Number 241.000.011
Code information (models, lots, serial numbers)
Part Number 241.000.011, lot number S2004
Other devices under the same FDA submission
11 devices cleared under K011335 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LCP 241.381Synthes GmbH · PLATE, FIXATION, BONE1 recall14 reports
- LCP 241.351Synthes GmbH · PLATE, FIXATION, BONE15 reports
- LCP 241.371Synthes GmbH · PLATE, FIXATION, BONE12 reports
- LCP 241.401Synthes GmbH · PLATE, FIXATION, BONE12 reports
- LCP 241.361Synthes GmbH · PLATE, FIXATION, BONE11 reports
- LCP 241.421Synthes GmbH · PLATE, FIXATION, BONE4 reports
- LCP 441.381Synthes GmbH · PLATE, FIXATION, BONE3 reports
- LCP 441.351Synthes GmbH · PLATE, FIXATION, BONE2 reports
- LCP 241.331Synthes GmbH · PLATE, FIXATION, BONE1 report
- LCP 241.341Synthes GmbH · PLATE, FIXATION, BONE1 report
- LCP 441.371Synthes GmbH · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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