ConMed Linvatec, Ultrapower Burs, Linvatec Corporation… recallZ-0711-2008 · Linvatec Corp. · initiated Aug 9, 2007
Terminated All recalls posted in April 2008
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
Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.
FDA root cause category: Packaging process control
What the company is doing
Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.
Recall details
- Recall number
- Z-0711-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 9, 2007
- Posted by the FDA
- Apr 8, 2008
- Recalling firm
- Linvatec Corp.
- Quantity
- 1181 units
- Product code
- GFF
- FDA submissions
- K781979
- Distribution
- Worldwide Distribution.
Product description
ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Lot Numbers: BBD14805 BBD14542 BBD14804 00949613 BBD08721 BBD11468 BBD14258 BBD15139 BBD16978 BBC91085 BBD08725 BBD11465 BBD13560 BBD14265 BBD14533 BBD17117 BBD18411 BBD08940 BBD11470 BBD13564 BBD14680 BBD14711 BBD18412 BBD08939 BBD15429 BBD15591 BBD16681 BBD14944 BBD17632 BBD17835 BBD08961 BBD17399 BBD08935 BBD14264 BBD15416 BBD17423 BBD14935 BBD17832 BBD08942 BBD14261 BBD17633 BBD08448 BBD13158 BBD16029 BBD08943 BBD13565 BBD16122 BBD17627 BBD08389 BBD14260 BBD15401 BBD16652 BBD11471 BBD14266 BBD14658 BBD17631 BBD17836 BBD08443 BBD13567 BBD14747 BBD08445 BBD13569 BBD17896 BBD08959 BBD17626 00950532 BBD08936 BBD13570 BBD08972 BBD15179 BBD08473 BBD13571 BBD14242 BBD15398 BBD17550 BBD08957 BBD08974 BBD16653 BBD08482 BBD17609 BBD08442 BBD15426 BBD16654 BBD08976 BBD14955 BBD08452 BBD09167 BBD14257 BBD16045 BBD08446 BBD15191 BBD16655 BBD08483 BBD15393 BBD16656 BBD08952 BBD11469 BBD16658 BBD17602 BBC89881 BBD08444 BBD16657 BBD17442 BBD08531 BBD15084 BBD17629 BBD14255 BBD14538 BBC92804 BBD15644 BBD16832
Other devices under the same FDA submission
1 device cleared under K781979 — 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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