Recall Z-1819-2013
Custom Spine, Inc. · initiated March 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019 The ISSYS LP Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine for pedicular and non-pedicular fixation.
Codes / lots: Catalog Number 048545; Lot Number L363
Reason for recall
On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specification. The screw length was 5 mm shorter in length than the required specification for the screw size. The product is laser marked 8.5mm X 45mm, but its length measured 40mm.
FDA-determined cause: Process control
Action taken
Custom Spine initiated a voluntary removal On 3/28/2013, Custom Spine initiated a voluntary removal of all 10 pieces of the ISSYS LP (8.5mm X 45mm screws) Lot 363. Distributors were contacted via phone and/or email and were asked to immediately return these parts to Custom Spine.
Details
- Recall number
- Z-1819-2013
- Initiated
- March 28, 2013
- Posted by FDA
- July 29, 2013
- Terminated
- October 24, 2013
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 18 units
- Distribution
- Nationwide Distribution including Nebraska and Virginia.
- Recalling firm
- Custom Spine, Inc., Parsippany, NJ