Recall Z-2375-2008
Theken Spine LLC · initiated July 11, 2008
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.
Codes / lots: Lot # A08F01E Exp Date 2010-06
Reason for recall
The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-2375-2008
- Initiated
- July 11, 2008
- Posted by FDA
- September 18, 2008
- Terminated
- September 20, 2011
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Quantity
- 33 syringes
- Distribution
- Nationwide Distribution --- including states of FL, OH, TX, and UT.
- Recalling firm
- Theken Spine LLC, Akron, OH