FDA Medical Device Recalls (openFDA)
Theken Spine LLC: Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
- Recall number
- Z-0272-2009
- Recalling firm
- Theken Spine LLC
- Product
- Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe.
- Status
- Terminated
- Initiated
- 2008-08-27
- Posted
- 2008-11-18
- Terminated
- 2012-04-13
- Reason
- The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.
- Root cause
- Other
- Action
- On 8/27/2008 the firm sent recall notification letters to each of their customers notifying them of the problem with the product. They were requested to return any remaining product back to the recalling firm and to call Customer Service at (866) 942-8698 for an RGA and to arrange shipment. On 8/28/2008 the firm conducted follow up contact each distributor via telephone.
- Quantity
- 115 total
- Distribution
- Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
- Lot, serial or model codes
- Part Number is 50-20-001. Lot #: 100549 Overall kit Exp. Date: 02/2010, Syringe Exp. Date 10/2009, Marrow Loc Exp. Date: 02/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 02/2010; Lot #103016 Overall kit Exp. Date: 10/2010, Syringe Exp Date: 10/2009, Marrow Loc Exp. Date: 10/2010 and "J" Style Bone Marrow Biopsy Needle Exp. Date: 10/2010.
- 510(k) numbers
- ["K993435"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 3002498892
- Firm city
- Akron
- Firm state
- OH
- 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