16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthoped
FDA device recall Z-2086-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
- Action taken
- DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients were asked to check inventory and return affected devices along with the completed response form. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FZO
- Quantity affected
- 100
- Distribution
- US Distribution to the states of : NJ, VA, OH, IN, MI, FL, WI, CA, TN, MD, NC, WA, UT, ID, MO, NV and KS.
- Date initiated
- 2015-06-24
- Date posted
- 2015-07-16
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
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