Comprehensive Srs 211272
Comprehensive Srs 211272 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K111746 on 15 Dec 2011 and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304683297), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00880304683297 | Date24 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK111746 | Date15 Dec 2011 | StatusActive |
Official records
- AccessGUDID record 00880304683297
- FDA 510(k) database K111746
Across registries
- FDA 510(k) K111746 decided 15 Dec 2011 Active
- FDA GUDID UDI-DI 00880304683297 listed 24 Oct 2015 Listed
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.
Timeline
- Cleared FDA 510(k) K111746
- Listed FDA GUDID 00880304683297
- Recall initiated FDA recalls Z-1173-2018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Comprehensive Srs
- Generic name
- Uncoated elbow humerus prosthesis
- Model / Ref / Catalog
- 211272
- Primary DI / UDI-DI
- 00880304683297
- 510(k) Number
- FDA product code
- KWT, KWS, JDC, MBF
- GMDN term
- Uncoated elbow humerus prosthesis
- Device class
- Class II
- Regulation number
- 888.3650, 888.3660, 888.3150, 888.3670
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional