Ultra Power Burs, Sterile, Single-Use recallZ-0041-05 · Linvatec Corp. · initiated Aug 26, 2004
Terminated All recalls posted in October 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Linvatec Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.
FDA root cause category: Packaging process control
What the company is doing
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.
Recall details
- Recall number
- Z-0041-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 26, 2004
- Posted by the FDA
- Oct 23, 2004
- Recalling firm
- Linvatec Corp.
- Quantity
- 58510 units
- Product code
- HRX
- FDA submissions
- K781979, K981636
- Distribution
- Distributed to 492 customers throughout the United States, and 301 customers internationally.
Product description
Ultra Power Burs, Sterile, Single-Use.
Code information (models, lots, serial numbers)
All product with an expiration date between August 2004 and August 2009.
Other devices under the same FDA submission
1 device cleared under K781979, K981636 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SURGAIRTOME TWO 00505800100Conmed Corporation · INSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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