Screw, Fixation, Bone, Non-Spinal, Metallic
FDA product code NDJ · Class II (moderate risk) · 21 CFR 888.3040 · Orthopedic
0510(k) clearances
0PMA approvals
4recalls
Implantimplanted device
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1694-2015 Class II | Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System…The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with… | Zimmer, Inc. | 04/29/2015Terminated |
| Z-1010-2014 Class II | INTERLOCKING IM SCREW 4.5 and INTERLOCKING IM SCREW LG Some items starting with codes…Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V.… | Zimmer, Inc. | 10/11/2013Terminated |
| Z-0836-2012 | Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM…On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504… | Biomet Microfixation, Inc. | 11/08/2010Terminated |
| Z-0835-2012 | Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM…On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504… | Biomet Microfixation, Inc. | 11/08/2010Terminated |