FDA Medical Device Recalls (openFDA)
Osteomed, Lp: OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
- Recall number
- Z-0008-2012
- Recalling firm
- Osteomed, Lp
- Product
- OSTEOMED SPINE Facet Fixation System PrimaLOK FF Threaded Implant Driver Shaft OsteoMed L.P. 3885 Arapaho Road, Addison, Texas 75001
- Status
- Terminated
- Initiated
- 2011-06-07
- Posted
- 2011-10-04
- Terminated
- 2012-12-04
- Reason
- Two of the Implant Driver Assembly tips were reported to break during surgery.
- Root cause
- Device Design
- Action
- OsteoMed LP sent an Urgent --Product Recall letter dated June 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately for affected inventory and promptly return any affected inventory to: OsteoMed LP Attan: Rebecca Ellis 3885 Arapaho Road Addison, Texas 75001 If the customer further distributed any of the affected product customers were instructed to immediately contact their accounts and advise them of the recall situation and have them return any devices they may have to OsteoMed at the above address. Customers were asked to complete and return the enclosed response immediately in the enclosed, postage paid envelope even if they do not have the device. For any questions please call (800) 456-7779.
- Quantity
- 20 units
- Distribution
- Nationwide Distribution including PA, TX, CA, IL IA, FL, CT, and MO
- Lot, serial or model codes
- Part Number 800-1212 lot # 1038452.
- 510(k) numbers
- ["K102438"]
- PMA numbers
- not on file
- Product code
- MRW
- Firm FEI
- 2027754
- Firm city
- Addison
- Firm state
- TX
- 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