Reported Jul 6, 2016 · Terminated
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog…
Medtronic Sofamor Danek USA, Inc. - Dallas Distribution
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: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution · 4620 N Beach St · Haltom City, TX · 76137-3219
Is this the product you have?
5 of 5 products
| Model / number | Product as published |
|---|---|
| — | Saw Sagittal Catalog Number: ES 300 |
ES300-R | Saw Sagittal Refurbished |
ES310 | Saw Saggital, Finger |
ES310-R | Saw Saggital, Finger Refurbished |
| — | Used to dissect bone in surgical applications. |
- Lot codes and dates
- All Serial Numbers.
- Amount recalled
- 368 devices
Where it was sold
Why it was recalled
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
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 Medtronic Sofamor Danek USA, Inc. - Dallas… 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.