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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Marrow Aspiration Kit

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  Class 2 Device Recall Bone Marrow Aspiration Kit see related information
Date Initiated by Firm August 27, 2008
Date Posted November 18, 2008
Recall Status1 Terminated 3 on April 13, 2012
Recall Number Z-0272-2009
Recall Event ID 49544
510(K)Number K993435  
Product Classification Biopsy Instrument - Product Code KNW
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Theken Spine LLC
1800 Triplett Blvd
Akron OH 44306-3311
For Additional Information Contact Wayne Stripe
330-745-8662
Manufacturer Reason
for Recall		 The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010.
FDA Determined
Cause 2		 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 in Commerce 115 total
Distribution Nationwide Distribution --- including states of CA, NC, NJ, NM, NY, TX, and UT.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KNW and Original Applicant = PROMEX, INC.
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