Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33
FDA device recall Z-0163-2013 · posted 2012-10-29 · Terminated
Recall details
- Recalling firm
- Stryker Spine
- Reason for recall
- Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm.
- Action taken
- Stryker Spine sent an Urgent Medical Device Field Correction Notification letter beginning July 5, 2012, to all affected customers. Teh letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the drill bit length in each respective drill guide prior to surgery to ensure the correct length protrudes through the guide. Customers with questions should call 201-760-8298. Customers were asked to report any adverse events or product quality problems to 1-888-457-7463.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 6154 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2012-07-05
- Date posted
- 2012-10-29
- Date terminated
- 2013-01-28
- Location
- Allendale, NJ
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