Acetabular Bone Screw D111-12-9145
by Signature Orthopaedics Pty Ltd
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09348215052539 | Date20 Sep 2022 | StatusListed |
Recalls
-
- Terminated Z-1694-2021
Product mislabeled, with the incorrect product inside the package.
-
- Terminated Z-0920-2018
This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Acetabular Bone Screw
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Model / Reference
- D111-12-9145
- Primary DI / UDI-DI
- 09348215052539
- 510(k) Number
- FDA Product Code
- LPH, MEH
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile
- Device Class
- Class II
- Regulation Number
- 888.3358, 888.3353
- GUDID distribution status
- In Commercial Distribution
Other devices from Signature Orthopaedics Pty Ltd
Properties
Other properties (8)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No