510(k) K112885 ยท HWC Screw, Fixation, Bone
ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 19, 2011 |
| Received | Sep 30, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112885
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2016 | Zimmer Manufacturing B.V. Zimmer Plates and Screws (ZPS)
4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200
4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400
4.0 mm Cancellous Screw Fully Thread Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 4 consists of all products under product code HWC, and same usage:
Item no:
47482002603 2.0 X 26 CORT SCREW CRUCI
47482002803 2.0 X 28 CORT SCREW CRUCI
47482003203 2.0 X 32 CORT SCREW CRUCI
Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 10consists of all product under product code HWC, and same usage:
Item no:
47484502601 4.5 X 26 CORT SCREW SELF
Product Usage:
A smooth or threaded metallic bone fixation fastener is a de Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 13 consists of all product under product code HWC
, and same usage:
Item no:
47486510002 6.5 X 100 CANC SCREW, 32M
Product Usage:
A smooth or threaded metallic bone fixation fastener is a de Terminated |
HWC | None listed |
| Mar 12, 2016 | Zimmer Manufacturing B.V. Product 18 consists of all product under product code: HWC and same usage:
Item no:
47248001441 CANC SCR 4.0MM X 14MM FUL
47248001641 CANC SCR 4.0MM X 16MM FUL
47248001840 CANC SCR 4.0MM X 18MM
4724 Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. Magna-Fx Cannulated Screw Fixation System
Bone Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. Magna-Fx Cannulated Screw Fixation System
Cannulated Bone Screw
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw 16 mm Thread Length
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw 32 mm Thread Length
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 6.5 mm Cancellous Screw Fully Threaded
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 4.5 mm Malleolar Screw
Sterile
zimmer Terminated |
HWC | None listed |
| Aug 16, 2014 | Zimmer, Inc. 4.0 mm Cancellous Screw, Partially Threaded
Sterile
Zimmer Terminated |
HWC | None listed |
| Feb 20, 2014 | Zimmer, Inc. PERI SCR. 3.5MM X 10MM
PERI SCR. 3.5MM X 12MM
PERI SCR. 3.5MM X 14MM
PERI SCR 3.5MM X 44MM STE
PERI SCR. 3.5MM X 65MM
PERI. SCR 4.0MM X24MM
PERI. SCR 4.0MM X40MM
PERI SCR. 4.0MMX14 Terminated |
HWC | None listed |
| Feb 20, 2014 | Zimmer, Inc. 1.5 X 6 CORT SCREW HEX/SE
2.0 X 6 CORT SCREW HEX/SE
2.0 X 10 CORT SCREW CRUCI
2.0 X 12 CORT SCREW CRUCI
2.0 X 14 CORT SCREW CRUCI
2.0 X 16 CORT SCREW HEX/S
2.0 X 16 CORT SCREW CRUCI
2.0 X 18 CORT SCRE Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.