Anatomical Shoulder™ Domelock® 01.04558.212
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 | Number00889024275720 | Date24 Sep 2016 | 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- Withdrawn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™ Domelock®
- Generic Name
- Humeral head prosthesis trial, reusable
- Model / Ref / Catalog
- 01.04558.212
- Primary DI / UDI-DI
- 00889024275720
- 510(k) Number
- FDA Product Code
- KWS, KWT, PHX, HSD
- GMDN Term
- Humeral head prosthesis trial, reusable
- Device Class
- Class II
- Regulation Number
- 888.3660, 888.3650, 888.3690
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Zimmer, Inc.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No