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Synthes Zero-P VA Implant 7 MM Height Parallel Sterile recallZ-0455-2014 · Synthes USA HQ, Inc. · initiated Sep 30, 2013

Class II Terminated All recalls posted in December 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 HQ, Inc. 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 potential non conformance was identified with the Zero-P VA plate where the screw could back out if the blocking mechanism is not visually confirmed to properly cover the head of the screw.

FDA root cause category: Process design

What the company is doing

Synthes sent an email message dated March 23, 2012, to the sales representative who received the affected product. The email identified the product, the problem, and the action to be taken. The letter requested the sales rep examine inventory, stop using the product, and quarantine the affected product to ensure that it will not be used. Synthes instructed the customer not to remove any product from their account or return any product without further instruction. For questions they were instructed to call 610-719-5364. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0455-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 30, 2013
Posted by the FDA
Dec 5, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
1
Product code
OVE
FDA submissions
K112068
Distribution
Nationwide Distribution - only AZ .

Product description

Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1.

Code information (models, lots, serial numbers)

part no. 04.647.117S, Plate implant no. 7706771, spacer lot no. 7675745

Other devices under the same FDA submission

29 devices cleared under K112068 — 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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