Home / Recalls / Zimmer Manufacturing B.V. / Z-1113-2016

Z-1113-2016 Class II Terminated

Recalled by Zimmer Manufacturing B.V. — Mercedita, PR

Recall Details

Product Type
Devices
Report Date
March 23, 2016
Initiation Date
January 11, 2016
Termination Date
April 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0

Product Description

Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: 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.

Distribution Pattern

US Nationwide Distribution

Code Information

lot no.: 62154349 62263555 62270747 62315652 62389960 62212034 62270748 62389957 37107513 62154348 62212021 62270746 62299145 62389956 62299145N

Other recalls by Zimmer Manufacturing B.V.

  • Z-1676-2016 Class II — Periarticular plating system, cancellous bone screw, partially threaded, hex hea (May 4, 2016)
  • Z-1675-2016 Class II — Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm le (May 4, 2016)
  • Z-1683-2016 Class II — Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular (May 4, 2016)
  • Z-1680-2016 Class II — Herbert Cannulated Bone Screw System, Bone Screw, 6.5 mm Dia., 45 mm Length 4711 (May 4, 2016)
  • Z-1678-2016 Class II — M/DN Intramedullary Fixation 4.2 mm Diameter Cortical Screw, 3.5 mm Hex Head, 45 (May 4, 2016)
  • Z-1679-2016 Class II — Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully (May 4, 2016)
  • Z-1684-2016 Class II — Trilogy self-tapping bone screw Bone screw 4.5x25 selftap 00625004525 Bone sc (May 4, 2016)
  • Z-1677-2016 Class II — Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm L (May 4, 2016)
  • Z-1673-2016 Class II — Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length (May 4, 2016)
  • Z-1674-2016 Class II — Zimmer Plates and Screws (ZPS) 2.7 mm Cortical Screw SelfTapping, 14 mm Length (May 4, 2016)