510(k) K032367 ยท HSB Rod, Fixation, Intramedullary And Accessories
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 12, 2003 |
| Received | Aug 1, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 14mmdx48cm left, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 14mmdx48cm right, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 14mmdx50cm left, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 20, 2017 | Zimmer Biomet, Inc. Fem IM Nail 14mmdx50cm right, Sterile,
Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 14 consists of all product under product code HSB
, and same usage:
Item no:
225600230 ASIA ONE-PIECE LAG SCREW
225600232 ASIA ONE-PIECE LAG SCREW
225600235 ASIA ONE-PIECE LAG SCREW
22560023 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 40 consists of all product under product code: HSB and same usage:
Item no:
225706565 ITST ANTI-ROTATION SCREW
225707065 ITST ANTI-ROTATION SCREW
225708065 ITST ANTI-ROTATION SCREW
225708565 Terminated |
HSB | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 55 consists of all product under product code: HSB and same usage:
Item no:
225900132 ONE-PIECE LAG SCREW 11MM
225900135 ONE-PIECE LAG SCREW 11MM
225900137 ONE-PIECE LAG SCREW 11MM
225900140 Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. ASIA ONE-PIECE LAG SCREW Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50) Terminated |
HSB | None listed |
| Feb 20, 2014 | Zimmer, Inc. ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900. Terminated |
HSB | None listed |
| Aug 4, 2009 | Zimmer Inc. Zimmer ITST Intertrochanteric/subtrochanteric fixation tapered reamer, nonsterile; REF 2258-50-00. Terminated |
HSB | None listed |
| Aug 4, 2009 | Zimmer Inc. Zimmer ITST Intertrochanteric/subtrochanteric fixation taper reamer - Asia, nonsterile; REF 2258-50-01. (Note: This product is not distributed in the United States). Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.