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Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm recallZ-0406-2014 · Synthes (USA) Products LLC · initiated Jul 30, 2013

Class II Terminated All recalls posted in November 2013

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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

FDA root cause category: Labeling mix-ups

What the company is doing

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.

Recall details

Recall number
Z-0406-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 30, 2013
Posted by the FDA
Nov 27, 2013
Recalling firm
Synthes (USA) Products LLC
Quantity
13
Product code
HRS
FDA submissions
K001941
Distribution
Worldwide Distribution - USA (nationwide) including IN, NY, WA, NE, MD, TX, AL, MI, and Internationally to Canada.

Product description

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.

Code information (models, lots, serial numbers)

Part No. 249.926, lot No. 8093100

Other devices under the same FDA submission

7 devices cleared under K001941 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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