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Terminated

ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, REF NEA3G; COPING GOLD NON-ENG. 4.5, REF NEA4G

FDA Recall Z-3206-2017 · Posted None

Recalling FirmZimmer Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-07-10
Date Terminated2019-08-05
Product Quantity13,235 products

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.

Firm Action

The affected customers are being provided instructions on how to obtain the supplemental IFUs for respective part numbers from appropriate E-labeling website along with a recall notice.

Root Cause

Under Investigation by firm

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)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013227SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANTSulzer Dental, Inc. · 2001-11-19K011028SCREW-VENT DENTAL IMPLANT SYSTEMSulzer Dental, Inc. · 2001-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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