FDA Medical Device Recalls (openFDA)
Interventional Spine Inc: Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.
- Recall number
- Z-3034-2011
- Recalling firm
- Interventional Spine Inc
- Product
- Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the 4.5mm BONE-LOK PLS a Implant (9024-00) are provided in Appendix C.
- Status
- Terminated
- Initiated
- 2011-03-15
- Posted
- 2011-08-18
- Terminated
- 2013-02-11
- 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. They were then asked to complete and return the enclosed response form as soon as possible. Questions were directed to call their regional directors. For questions regarding this recall call 949-472-0006.
- Quantity
- 407 units
- Distribution
- Nationwide Distribution including CO, CT, FL, KY, LA, MA, MO, NC, NY, OK, OR, TN, TX, VA & WI
- Lot, serial or model codes
- CATALOG NO. 9045-01, LOT #'s: 050709-8, 050809-C, 051209-D, 060209-A, 060809-C, 061709-C, 062009-0, CATALOG NO. 9045-02, LOT #'s: 050809-B, 051309-8,060809-8, 061 709-0,060209-A
- 510(k) numbers
- ["K043351"]
- PMA numbers
- not on file
- Product code
- MRW
- Firm FEI
- 3003523239
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28