High FDA (Devices)·Z-2033-2012·Announced 2012-07-25

Stryker AVS Navigator Trials Recalled for Shaft Failure

Stryker Spine is recalling AVS Navigator Trials because the shaft may fail at the junction of the trial head.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural failure of a medical device used intra-operatively, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Stryker Spine is recalling 273 units of AVS Navigator Trials, sizes 6mm through 15mm. These medical devices are intended to measure the height of the disc space intra-operatively.

The recall was initiated because Stryker Spine began receiving reports in February 2011 that the shaft of the AVS Navigator trial failed at the junction of the trial head. The affected units were distributed nationwide.

Healthcare providers should stop using the affected AVS Navigator Trials and contact Stryker Spine for instructions on how to return or replace the devices.

The recalled product

Product: Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker 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 3
Manufacturer: Stryker Spine
Category: Medical Device — Spine Instrumentation
Hazard: structural-failure
Affected units: 273

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Class I
48392207
48392208
48392209
48392210
48392211
48392212
48392213
48392214
48392215. Lot Code: 104864
104866
104867
104868
104869
104870
10E331
104871
104872
104873
104874

Distribution

Distributed nationwide across the United States.

Same manufacturer · Stryker Spine

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