Recall Z-1870-2013
SpineFrontier, Inc. · initiated April 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Codes / lots: Lot: 56H26
Reason for recall
Malfunction of slap hammer.
FDA-determined cause: Device Design
Action taken
The firm, SpineFrontier, sent an advisory notice entitled "URGENT April 25, 2013 S-LIFT Slap Hammer Removal" dated April 25, 2013 via email to its customers. The notice described the product, problem and action to be taken. The notice requested the removal of all distributed SLIFT Slap Hammer with listed lot number. The customers were instructed to complete and return the URGENT S-LIFT Slap Hammer Removal ACKNOWLEDGEMENT FORM via fax to: SpineFrontier, Inc., 978-232-3991 or email to customerservice@spinefrontier.com. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.
Details
- Recall number
- Z-1870-2013
- Initiated
- April 25, 2013
- Posted by FDA
- August 1, 2013
- Terminated
- January 9, 2014
- Product code
- FZY – Hammer, Surgical
- Quantity
- 3
- Distribution
- US distributions to states of: KS and TX.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA