Zimmer Dental Inc: Medical Device Recall in 2017 - (Recall #: Z-3204-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223

Product Classification:

Class II

Date Initiated: July 10, 2017

Date Posted: October 4, 2017

Recall Number: Z-3204-2017

Event ID: 77911

Reason for Recall:

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.

Status: Terminated

Product Quantity: 349 products

Code Information:

lot # 63062148, 63386541, 0300481, 63386544, 63536617, 63426541, 3460410, 63426542, 63503028

Distribution Pattern:

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, Malaysia, Turkey, Serbia, Pakistan, Korea (the Republic of)

Voluntary or Mandated:

Voluntary: Firm initiated