Tsp Hip Fx Plating Systemscrew Extractor, 7.5mm Screw 14-451565
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00887868129797 | Date26 Sep 2016 | StatusListed |
Recalls
-
- Terminated Z-1347-2020
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
-
- Terminated Z-2240-2016
The screw may fracture at the junction of the shaft and the head during implantation. The patient may retain a foreign body if the fractured screw cannot be removed. Soft tissue irritation will not occur as the retained portion of the screw is below the surface of the plate. A delay in surgery less than 30 minutes may occur.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Tsp Hip Fx Plating Systemscrew Extractor, 7.5mm Screw
- Generic Name
- Orthopaedic implantation sleeve, reusable
- Model / Ref / Catalog
- 14-451565
- Primary DI / UDI-DI
- 00887868129797
- 510(k) Number
- FDA Product Code
- KTT, JDO
- GMDN Term
- Orthopaedic implantation sleeve, reusable
- Device Class
- Class II
- Regulation Number
- 888.3030
- GUDID distribution status
- In Commercial Distribution
Other devices from Biomet Orthopedics, Inc.
Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No