Recall Z-1155-2016— Zimmer Manufacturing B.V.
Class II · Terminated
Class II FDA medical device recall by Zimmer Manufacturing B.V., initiated 2016-01-11, terminated 2017-04-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile..
- Recalling firm
- Zimmer Manufacturing B.V.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-11
- Terminated
- 2017-04-13
- Firm location
- Mercedita, PR, United States
Product description
Product 57 consists of all product code: JDI and same usage: Item no: 763401000 PRESSFIT FEM ST FX 10 X 115 763401100 PRESSFIT FEM ST FX 11 X 1 763401200 PRESSFIT FEM ST FX 12 X 1 763401300 PRESSFIT FEM ST FX 13 X 1 763401400 PRESSFIT FEM ST FX 14 X 1 763401500 PRESSFIT FEM ST FX 15 X 1 For use in total or hemi hip arthroplasty
Reason for recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Data sourced from openFDA. This site is unofficial and independent of the FDA.