Reported Oct 4, 2017 · Terminated
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD…
Zimmer Dental Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Dental Inc · 1900 Aston Ave · Carlsbad, CA · 92008-7308
Is this the product you have?
ABUT GOLD FRICTION-FITREF HLA3GABUT GOLD FRICTION-FITREF HLA4GCOPING GOLD ENG 5.7 MMREF HLA5GCOPING GOLD NON-ENG. 3.5REF NEA3GCOPING GOLD NON-ENG. 4.5REF NEA4G
- Lot codes and dates
101 of 101 codes
lot # 631966086322432263260962633274286332742763346417633556616335566463355665633766606337666263376661633766636339541063395405633954066339540763395404634062196340622163419209634192106345633163456332634655996346690763466908634746286347707563488535634844506348853663497308634973056349730763510220635252496352525063530399635291166355637363561213632316116323214863235422632602026326020363346423633464216335667863356675633766556337665763376654633766536337665663395415633954136339541463403215
- Amount recalled
- 13,235 products
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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