Spacer W/Bolt 10495
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887868001567 | Date24 Oct 2015 | StatusListed |
Recalls
-
- Terminated Z-0508-2012
DePuy has received three complaints concerning oversized bolt threads in the Offset Wire Fixation Bolts used in the Ace- Fischer External Fixation System. This could lead to the inability to properly thread the nut onto the bolt.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Spacer W/Bolt
- Generic Name
- External orthopaedic fixation system, single-use
- Model / Ref / Catalog
- 10495
- Primary DI / UDI-DI
- 00887868001567
- FDA Product Code
- HXK, JDW, KTT
- GMDN Term
- External orthopaedic fixation system, single-use
- Device Class
- Class I
- Regulation Number
- 888.4540, 888.3040, 888.3030
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (10)
- Sterile: 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
- Manufacturing Date: No