Medical Device Recall: Z-0043-2007

FDA Recalls dataset · Firm: Bioplate Inc · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-09-12 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0043-2007.

Recall Res Number
Z-0043-2007
Recalling Firm / Manufacturer
Bioplate Inc
FEI Number
1000518793
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-09-12
Date Posted
2006-10-19
Date Terminated
2011-09-14
Product Code
JEY
Event Number
36362
Product Quantity
36 units
Product Description Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Reason for Recall Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
Action Details Customers were notified via telephone initially on 09/14/2006 to return product, and this was followed up within two days with a certified mail/return receipt required, recall notification letter. 100% of the consignees will be notified of the recall. Bioplate will fax and call non-responsive customers afler 5 days via telephone call. Customers not responding to the first recall notification will be sent a second notification certified mail recall notification.
Distribution Pattern Nationwide to: CA, DC, GA, MI, OH, & PA
Code Information / Serial Numbers Lot number: S29640905

Related Establishments / Registrations

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