FDA Medical Device Recalls (openFDA)
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 number
- Z-2375-2008
- Recalling firm
- Theken Spine LLC
- 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.
- Status
- Terminated
- Initiated
- 2008-07-11
- Posted
- 2008-09-18
- Terminated
- 2011-09-20
- Reason
- The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06.
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 33 syringes
- Distribution
- Nationwide Distribution --- including states of FL, OH, TX, and UT.
- Lot, serial or model codes
- Lot # A08F01E Exp Date 2010-06
- 510(k) numbers
- ["K053228"]
- 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