Reported Jul 27, 2022 · Terminated
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Aesculap Implant Systems LLC
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: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Lot codes and dates
- UDI-DI04046964719622
- Amount recalled
- 16
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
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 Aesculap Implant Systems LLC 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.