FDA-Device2016-05-25Class II

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

Zimmer Manufacturing B.V.
Hazard

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

Sold states
Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Affected count
1199
Manufactured in
Turpeaux Industrial Park Rd 1 km 123.4, N/A, Mercedita, PR, United States
Products
Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2016

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