Recall Z-3033-2011 ยท MRW System, Facet Screw Spinal Device
Interventional Spine Inc
PERPOS PLS, CATALOG #'s 9045-01 & 9045-02 A sterile, medical device kit consisting of the components listed in Table 1-1 below. The kit is used by medical professionals to stabilize the spine as an aid to fusion through immobilization of the facet joints.
| Date | Aug 18, 2011 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | This recall has been initiated due to Pull Pins that may disengage from the Facet Screw during the compression step, requiring that compression be completed with a device driver rather than the compression tool. Use of this product may result in less than optimal compression leading to pseudoarthrosis, non-union or facet pain. |
| Root cause | Other |
| Action | Interventional Spine, Inc. sent a recall letter dated March 15, 2011, informing consignees of the product, the problem, and the action to be taken. Consignees were asked to immediately examine their inventory and quarantine product subject to recall. In addition, if they distributed the product further they were asked to notify Jane Metcalf, the Vice President of Quality Assurance at once. Interventional Spine further informed consignees that the recall was being carried out to the individual consignee level. And their assistance was appreciated and necessary to prevent use of this product. |
| Quantity | 553 units |
| Distribution | Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062391 | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 Triage Medical, Inc., Sep 14, 2006 |