Theken Spine LLC FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates.
Brand
Theken Spine LLC
Lot Codes / Batch Numbers
Lot # A08F01E Exp Date 2010-06
Products Sold
Lot # A08F01E Exp Date 2010-06
Theken Spine LLC is recalling FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box fol due to The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
Recommended Action
Per FDA guidance
In a letter dated July 11, 2008, the firm asked their customers to check their inventory for the suspect product. If found they are to return the product for credit or replacement. The firms asks customers to contact them if any units were used for surgery and they will send the correct patient labels. If additional information is needed, customers are to contact Theken Spine Regulatory Affairs or the Quality Department.
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