Recall Z-1117-2016— 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 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 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 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 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.