FDA Medical Device Recalls (openFDA)
Theken Spine LLC: iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
- Recall number
- Z-1965-2009
- Recalling firm
- Theken Spine LLC
- Product
- iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
- Status
- Terminated
- Initiated
- 2008-08-26
- Posted
- 2009-09-03
- Terminated
- 2012-03-09
- Reason
- Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04.
- Root cause
- Error in labeling
- Action
- Theken Spine, LLC contacted the Consignee August 26, 2008 via telephone and instructed them to inventory their stock and return affected product to the firm. For further questions, contact Theken Spine, LLC at 1-330-475-8662.
- Quantity
- 22 units
- Distribution
- Nationwide Distribution -- TX.
- Lot, serial or model codes
- Model Number: 50-05-0010; Lot Number: A07D02B.
- 510(k) numbers
- ["K040134"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3002498892
- Firm city
- Akron
- Firm state
- OH
- 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