Reported Jul 25, 2012 · Terminated
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0)…
Stryker Spine
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: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- Stryker AVS Navigator
- Trials 6mm-15mm Manufactured byStryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France 33610
- Intended UseThe trials are designed and intended to measure the height of the disc space intra-operatively
- Lot codes and dates
- Class I; 510(k)
- Exempt DescriptionAVS¿ Navigator Trials. Size 6mm -15mm
- Catalog Number
48392206483922074839220848392209483922104839221148392212483922134839221448392215
- Lot Code
10486410486610486710486810486910487010E331104871104872104873104874104875
- Amount recalled
- 273 units
Where it was sold
- Nationwide
Why it was recalled
Beginning in February 2011, Stryker Spine began receiving reports related to the shaft of the AVS Navigator trial failing at the junction of the trial head.
This product could cause temporary or reversible health problems — stop using it.
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