Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-3205-2017Class II

Thread Retrieval Drill Ref 2224

ZimVie US Corp LLC / initiated 2017-07-10 / Terminated

Zimmer Dental Inc began a recall of THREAD RETRIEVAL DRILL REF 2224 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-3205-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
ZimVie US Corp LLC
Product
Thread Retrieval Drill Ref 2224
Product code
DZA Drill, Dental, Intraoral
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.
FDA root cause
Under Investigation by 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.
Quantity in commerce
237 products
Distribution
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)
Product codes and lots
lot # 63241114, 63321266, 63426543

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-3205-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-3204-2017Class IITerminatedVoluntary: Firm initiated
Z-3205-2017Class IITerminatedVoluntary: Firm initiated
Z-3206-2017Class IITerminatedVoluntary: Firm initiated
Z-3207-2017Class IITerminatedVoluntary: Firm initiated
Z-3208-2017Class IITerminatedVoluntary: Firm initiated
Z-3209-2017Class IITerminatedVoluntary: Firm initiated
Z-3210-2017Class IITerminatedVoluntary: Firm initiated