Linvatec Corp. Ultra Power Burs, Sterile, Single-Use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ultra Power Burs, Sterile, Single-Use.
Brand
Linvatec Corp.
Lot Codes / Batch Numbers
All product with an expiration date between August 2004 and August 2009.
Products Sold
All product with an expiration date between August 2004 and August 2009.
Linvatec Corp. is recalling Ultra Power Burs, Sterile, Single-Use. due to The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
Recommended Action
Per FDA guidance
Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.
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