Alloclassic® Zweymüller® SLO 01.00121.000
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024278028 | Date29 Aug 2016 | StatusListed |
Recalls
-
- Terminated Z-0214-2013
Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Alloclassic® Zweymüller® SLO
- Generic Name
- Press-fit hip femur prosthesis, modular
- Model / Reference
- 01.00121.000
- Primary DI / UDI-DI
- 00889024278028
- 510(k) Number
- FDA Product Code
- KWY, LZO, KWL, JDI
- GMDN Term
- Press-fit hip femur prosthesis, modular
- Device Class
- Class II
- Regulation Number
- 888.3390, 888.3353, 888.3360, 888.3350
- GUDID distribution status
- Not in Commercial Distribution
- MRI Safety
- MR Conditional
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