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.
FDA Recall Z-1819-2013 · Posted 2013-07-29
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Recalling FirmCustom Spine, Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2013-03-28
Date Terminated2013-10-24
Product Quantity18 units
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution including Nebraska and Virginia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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