Reported Nov 14, 2012 · Terminated
Dynesys¿ HA Pedicle + set screw
Zimmer, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer, Inc. · 345 E Main St · Warsaw, IN · 46580-2746
Is this the product you have?
- Dynesys¿ HA Pedicle + set screw
- Lot codes and dates
- REF Numbers
01.03756.04001.03756.05001.03756.44001.03756.44501.03756.45001.03756.45501.03757.23501.03757.24001.03757.24501.03757.25001.03757.25501.03758.04001.03758.050 and 01.03758.055
- Lot
23993602502246251916023233822399361245937725007512383797242504424491472373116241190723233992344133234413324265582359295242656024562682502250232344624888822444047232344924330712323450
- REF Numbers
- Amount recalled
- 1247
This recall covers 40 products
The agency filed one notice per product. You are reading one of them; the other 39 are below.
27 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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