Zimmer Austin, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Zimmer Austin, Inc. makes
Zimmer Austin, Inc. manufactures orthopedic revision stems for knee arthroplasty, including the CLS SPOTORNO STEM and the WAGNER SL REVISION STEM LATERAL. These devices are designed for use in complex knee replacements, particularly in cases requiring lateral revision procedures.
The company’s products fall under FDA Class II medical devices and are listed via 510(k) clearance in the United States. The manufacturer is based in the US.
Catalogue
Cls Spotorno Stem Ref K042249
510(k) 510(k)Wagner Sl Revision Stem Lateral Ref K043356
510(k) 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Zimmer Austin, Inc., initiated on 2004-12-17. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2004
- 17 Dec 2004 Z-0539-05 Unclassified (pre-2012) Terminated Risk of adapter disassociation from mating components when assembled improperly or when subjected to high-stress femoral applications.
Frequently asked questions
How many devices does Zimmer Austin, Inc. have in the registry?
The registry currently lists 2 devices for Zimmer Austin, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Zimmer Austin, Inc.'s devices?
Among its 2 most recently registered devices, Zimmer Austin, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Zimmer Austin, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Zimmer Austin, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Zimmer Austin, Inc.?
FDA recall records list 1 recall initiated by Zimmer Austin, Inc., the most recent initiated on 2004-12-17. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Zimmer Austin, Inc. in the registry?
The most recently registered devices listed for Zimmer Austin, Inc. include CLS SPOTORNO STEM and WAGNER SL REVISION STEM LATERAL.