Echo® Bi-Metric® Hip System 192520
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887868274039 | Date13 Nov 2018 | StatusListed |
Recalls
-
- Terminated Z-2821-2018
Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.
-
- Terminated Z-0300-2018
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
-
- Terminated Z-0442-2013
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Echo® Bi-Metric® Hip System
- Generic Name
- Press-fit femoral stem prosthesis
- Model / Ref / Catalog
- 192520
- Primary DI / UDI-DI
- 00887868274039
- 510(k) Number
- FDA Product Code
- LZO, KWL, KWY, JDI, MAY, LPH, LWJ, MEH, KWZ, KWA
- GMDN Term
- Press-fit femoral stem prosthesis
- Device Class
- Class II
- Regulation Number
- 888.3353, 888.3360, 888.3390, 888.3350, 888.3358, 888.3310, 888.3330
- GUDID distribution status
- In Commercial Distribution
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No