FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization.
FDA device recall Z-2375-2008 · posted 2008-09-18 · Terminated
Recall details
- Recalling firm
- Theken Spine LLC
- Reason for recall
- The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- MQV
- Quantity affected
- 33 syringes
- Distribution
- Nationwide Distribution --- including states of FL, OH, TX, and UT.
- Date initiated
- 2008-07-11
- Date posted
- 2008-09-18
- Date terminated
- 2011-09-20
- Location
- Akron, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THERIGRAFT TCP PUTTY BONE VOID FILLER (K053228) | Therics, LLC | 2006-01-31 |