Reported Jul 8, 2015 · Terminated
Spine Wave Access Kit, Catalog Number 10-1530 Package contents: RLSP494-Rhythmlink Monopolar Stimulating Probe and…
Spine Wave, 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: Spine Wave, Inc. · 3 Enterprise Dr Ste 302 · Shelton, CT · 06484-4694
Is this the product you have?
- Spine Wave Access Kit
- Catalog Number 10-1530 Package contentsRLSP494-Rhythmlink Monopolar Stimulating Probe and 10-1525 Disposable Dilator Set
- Product UsageThe Spine Wave Access Kit is comprised of a sterile monopolar stimulating probe (individually packaged by Rhythmlink International) and a set of three sterile disposable dilators (individually packaged by Spine Wave). The Rhythmlink International Monopolar Stimulating Instrument is indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots
- Lot codes and dates
- Lot Codes
092514Z120814A011415H and 022415F
- Lot Codes
- Amount recalled
- 121 units
Where it was sold
Why it was recalled
Mislabeled outer carton: Monopolar Probe is listed as 200 x 1.5mm when it should be listed as 280 x 1.5mm
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Spine Wave, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.