FDA Medical Device Recalls (openFDA)
SpineNet: SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
- Recall number
- Z-2107-2013
- Recalling firm
- SpineNet
- Product
- SpineNet Bone Marrow Aspiration Needle Kit (which is the Ranfac Bone Marrow Aspiration Needle #74150-01M). Use to aspirate bone morrow.
- Status
- Terminated
- Initiated
- 2013-02-04
- Posted
- 2013-08-27
- Terminated
- 2013-11-15
- Reason
- SpineNet was marketing this device to be used with SpineNet ACC device without FDA clearance or approval.
- Root cause
- No Marketing Application
- Action
- SpineNET sent a "VOLUNTARY PRODUCT RECALL" letter dated 02/04/2013 to Halifax Medical Center. The letter identified the product, problem, and actions to be taken by the customer. Contact the firm at 407-539-2483 for questions regarding this notice.
- Quantity
- 100 units
- Distribution
- Distributed to one customer in Florida.
- Lot, serial or model codes
- Lot # 22754F16 and #25854I17
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAA
- Firm FEI
- 3006755626
- Firm city
- Winter Park
- Firm state
- FL
- 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