BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synt

FDA device recall Z-0401-2013 · posted 2012-11-20 · Terminated

Recall details

Recalling firm

Kerr Corporation

Reason for recall

The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.

Action taken

Kerr Corporation sent an Urgent Medical Device Correction letter and acknowledgement form dated October 25, 2012, to all affected customers via USPS First Class. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: "...review the table with product description , part numbers and lot numbers to determine if they have any of the affected product in their inventory and confirm that they were aware of the additional placement instructions necessary to achieve desired ossification results detailed in the paragraph in the letter. Customers were instructed to contact Kerr Customer Care at 18005377123 if they have any questions. Customers were also instructed to complete and fax back the enclosed Acknowledgement Form to 714-288-4609 in order to confirm their receipt of this correction regardless of whether they have any affected product in their inventory. For questions regarding this recall call 714-516-7400.

Root cause

Labeling design

Status

Terminated

Product code

LYC

Quantity affected

22,410 units

Distribution

Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .

Date initiated

2012-10-25

Date posted

2012-11-20

Date terminated

2013-09-23

Location

Orange, CA