CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report
Max Implant System - Bone Tap for use with diameter Max Implant recalled
Keystone Dental is recalling Max Implant System - Bone Tap for use with diameter Max Implant, distributed nationwide in the US. The recall was initiated on 16 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0718-2018
- FDA event ID
- 79066
- Recalling firm
- Keystone Dental, Burlington, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jun 2017
- FDA classified
- 26 Feb 2018
- Reported
- 7 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Dental Devices
Timeline
| 16 Jun 2017 | Recall initiated by company | |
| 26 Feb 2018 | Classified by FDA | +255 days |
| 7 Mar 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Product as listed by the FDA
Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
Where it was distributed
USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada
Nationwide CaliforniaColoradoFloridaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMontanaNorth CarolinaNew HampshireNew YorkOhioPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Which lots are affected?
Catalog Number D-TAP-MAX7-7, Lot 31444
Where was it sold?
USA (nationwide) Distribution to the states of : CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI and WV; and Internationally to Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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