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FDA Medical Device Recalls (openFDA)

Medical Device Technologies, Inc.: Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.

Recall number
Z-0452-2009
Recalling firm
Medical Device Technologies, Inc.
Product
Angiotech, T-Lok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. The device is intended for use during Bone Marrow Biopsy.
Status
Terminated
Initiated
2008-07-16
Posted
2009-01-06
Terminated
2009-04-21
Reason
Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
Root cause
Other
Action
Each consignee was notified of recall by letter on 07/16/2008 . The letter described the problem and indicated the corrective action to be taken. A Customer Acknowledgment Form with request to fax form to firm's QA Dept was provided. Contact Medical Device Technologies, Inc., Quality Assurance Department at 1.352.338.0440, ext 350 and 353 for assistance.
Quantity
180 Units
Distribution
Nationwide - FL, TX, WI, PA, MN, SC, NC, KY, TN, CA, AR, OR, NJ, and IA.
Lot, serial or model codes
Lot Number 81291N9Y
510(k) numbers
["K980196"]
PMA numbers
not on file
Product code
KNW
Firm FEI
1036710
Firm city
Gainesville
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

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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

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