Bioplate Inc Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45
Brand
Bioplate Inc
Lot Codes / Batch Numbers
Lot number: S29640905
Products Sold
Lot number: S29640905
Bioplate Inc is recalling Bioplate Resorbable Bone Fixation Tack, Catalog Number: 89-0120, Item Number: SG#-45 due to Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not steriliz. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026