S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments th
FDA device recall Z-1870-2013 · posted 2013-08-01 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Malfunction of slap hammer.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FZY
- Quantity affected
- 3
- Distribution
- US distributions to states of: KS and TX.
- Date initiated
- 2013-04-25
- Date posted
- 2013-08-01
- Date terminated
- 2014-01-09
- Location
- Beverly, MA
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