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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04.
Brand
Theken Spine LLC
Lot Codes / Batch Numbers
Model Number: 50-05-0010, Lot Number: A07D02B.
Products Sold
Model Number: 50-05-0010; Lot Number: A07D02B.
Theken Spine LLC is recalling iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50- due to Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026