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.
Recall
- Recall Number
- Z-1870-2013
- Event Number
- 65033
- Firm
- SpineFrontier, Inc.
- FEI Number
- 3005977257
- Product Code
- FZY
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 25, 2013
- Posted
- August 1, 2013
- Terminated
- January 9, 2014
- Address
- 500 Cummings Ctr, Ste 3500, Beverly, MA, 01915-6516
Description
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.
Malfunction of slap hammer.
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 [email protected]. Please feel free to contact SpineFrontier at 978-232-3990 with any questions.
US distributions to states of: KS and TX.
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