SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora,

FDA device recall Z-1545-2013 · posted 2013-06-14 · Terminated

Recall details

Recalling firm

Ormco/Sybronendo

Reason for recall

A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord.

Action taken

The firm SybronEndo sent a "FIELD CORRECTION ACTION" letter dated January 30, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were requested to review and determine if they have any of the affected equipment in their inventory; Note: the equipment itself has not been modified in any way, and therefore there is no change in the performance; customers should continue to use the equipment in the same manner they have in the past:; Note: SynbronEndo has enclosed the cautionary label along with instructions for proper placement of the affected equipment; the customers should apply the enclosed cautionary statement label to Elements Obturation Unit and/or Replacement AC Power Cord as per instructions and complete and return the FIELD CORRECTION ACKNOWLEDGEMENT FORM ,whether or not they have any affected equipment in their inventory, via Fax to: 909-962-5605. For questions regarding this recall call 714-516-7602. Note: If you are an authorized SybronEndo international distributor, we request that you identify those customers that may have been shipped the affected lots of equipment and contact these customers to inform them of the issue within forty-eight (48) hours of receipt of this notification. If you have any questions, contact SybronEndo Customer Care at 1-800-346-3636.

Root cause

Labeling mix-ups

Status

Terminated

Product code

EKR

Quantity affected

3615 unit total

Distribution

Worldwide Distribution - USA (nationwide) and the countries of Australia, Azerbaijan, Belgium, Canada, China, Cyprus, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Icela

Date initiated

2013-01-17

Date posted

2013-06-14

Date terminated

2013-11-07

Location

Glendora, CA

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