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Recall Observatory FDA recall evidence

Device product

STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K

Z-1179-2018

October 16, 2017

Class III

Product summary

Firm
Keystone Dental Inc
Event
Event 79297
Status
Terminated
Classification
Class III
Quantity
55
Official record key
device-enforcement:Z-1179-2018

Official wording

Reason: A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.

Code information: Lots: 35026, 35579, 36133

Distribution pattern: International Distribution to: Germany only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.