FDA Medical Device Recalls (openFDA)
Linvatec Corp.: 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***''.
- Recall number
- Z-1551-05
- Recalling firm
- Linvatec Corp.
- Product
- 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***''.
- Status
- Terminated
- Initiated
- 2005-02-22
- Posted
- 2005-09-21
- Terminated
- 2012-07-07
- Reason
- 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.
- Root cause
- Other
- Action
- Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.
- Quantity
- 3,273 Units
- Distribution
- Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K013131"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28