Anatomical Shoulder™ 01.04201.163
by Zimmer, Inc.
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024274563 | Date16 Oct 2015 | StatusListed |
Recalls
-
- Terminated Z-2003-2016
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Anatomical Shoulder™
- Generic Name
- Total shoulder prosthesis
- Model / Reference
- 01.04201.163
- Description
- Humeral Stem uncemented Ø16-120
- Primary DI / UDI-DI
- 00889024274563
- 510(k) Number
- FDA Product Code
- PHX, HSD, KWT, KWS
- GMDN Term
- Total shoulder prosthesis
- Device Class
- Class II
- Regulation Number
- 888.3660, 888.3690, 888.3650
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 120 MillimeterOuter Diameter — 16 Millimeter
Other devices from Zimmer, Inc.
Properties
Other properties (7)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No