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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Stryker Spine
- Hazard
- 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.
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