Product is an Orthopedic device contained in a Peel Foil… recallZ-1551-05 · Linvatec Corp. · initiated Feb 22, 2005
Terminated All recalls posted in September 2005
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
Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.
FDA root cause category: Other
What the company is doing
Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
Recall details
- Recall number
- Z-1551-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 22, 2005
- Posted by the FDA
- Sep 21, 2005
- Recalling firm
- Linvatec Corp.
- Quantity
- 3,273 Units
- FDA submissions
- K013131
- Distribution
- Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
Product description
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF***QTY 1 BioScrew XtraLok ***STERILE***Linvatec, LINVATEC CORPORATION LARGO, FL 33773 USA***''.
Code information (models, lots, serial numbers)
Lot #''s BBB32078, BBB34094, BBB34999, BBB35880, BBB38626, BBB48838, BBB49880, BBB59210, BBB53860, BBB55923, BBB59491, BBB65474, BBB66408, BBB68488, BBB31428, BBB34095, BBB35002, BBB36673, BBB48839, BBB51999, BBB55022, BBB59493, BBB66410, BBB35055, BBB50780, BBB61023, BBB34089, BBB35879, BBB37714, BBB48840, BBB52911, BBB55921, BBB65475, BBB30602, BBB31323, BBB49881, BBB52912, BBB67472, BBB52000.
Other devices under the same FDA submission
1 device cleared under K013131 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BIOSCREW XTRALOK C8028Conmed Corporation · Screw, fixation, bone1 report
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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