Comprehensive Srs Seas Head Trial 405192
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304542389 | Date27 Oct 2016 | StatusListed |
Recalls
-
- Terminated Z-1173-2018
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Comprehensive Srs Seas Head Trial
- Generic Name
- Humeral head prosthesis trial, reusable
- Model / Ref / Catalog
- 405192
- Primary DI / UDI-DI
- 00880304542389
- 510(k) Number
- FDA Product Code
- KWT, KWS, MBF, JDC
- GMDN Term
- Humeral head prosthesis trial, reusable
- Device Class
- Class II
- Regulation Number
- 888.3650, 888.3660, 888.3670, 888.3150
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Biomet Orthopedics, 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