Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr
FDA device recall Z-1819-2013 · posted 2013-07-29 · Terminated
Recall details
- Recalling firm
- Custom Spine, Inc.
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 18 units
- Distribution
- Nationwide Distribution including Nebraska and Virginia.
- Date initiated
- 2013-03-28
- Date posted
- 2013-07-29
- Date terminated
- 2013-10-24
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ISSYS LP SPINAL FIXATION SYSTEM (K111099) | Custom Spine, Inc. | 2011-05-05 |
| ISSYS LP SPINAL FIXATION SYSTEM (K072866) | Custom Spine, Inc. | 2007-12-13 |
| ISSYS LP SPINAL FIXATION SYSTEM (K070281) | Custom Spine, Inc. | 2007-06-11 |