Zimmer Dental Inc recalls IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF…

Recall date

July 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3210-2017

FDA classification

Class II

Brand / firm

Zimmer Dental Inc

Sold / distributed

US, Canada, France, Israel, Hong Kong, Netherlands, Japan, Italy, Belgium, Thailand, Saudi Arabia, Taiwan (Province of China), United Arab Emirates, Panama, Venezuela (Bolivarian Republic of), Chile, Colombia, Australia, Singapore, Costa Rica, Morocco, Trinidad and Tobago, Lebanon, Ecuador, Malaysi…

Why it was recalled

Zimmer Biomet is conducting a medical device field correction for various dental products due to several parts being shipped to the customer with only standard IFUs. All the products were missing supplemental IFUs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; IMPLANT 1-PC STR 3.0X10, REF ZOP30S10; IMPLANT, 1-PC,STR,3.0X11.5MM, REF ZOP30S11; IMPLANT,1 -PC,STR,3.0X13MM, REF ZOP30S13