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FDA Medical Device Recalls (openFDA)

The Anspach Effort, Inc.: Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.

Recall number
Z-1629-2014
Recalling firm
The Anspach Effort, Inc.
Product
Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine.
Status
Terminated
Initiated
2013-12-03
Posted
2014-05-16
Terminated
2016-04-18
Reason
The Irrigation Clips were assembled with the incorrect (smaller) clips.
Root cause
Mixed-up of materials/components
Action
The firm, Anspach, sent an URGENT: Medical Device Removal letter dated December 3, 2013 to its customer. The letter described the product, problem and actions to be taken. Should you have any queries, please do not hesitate to contact Aspach Customer Support at (800) 327-6887.
Quantity
150
Distribution
US Nationwide Distribution in the state of Mississippi.
Lot, serial or model codes
Batch G323082757.
510(k) numbers
["K030576"]
PMA numbers
not on file
Product code
FRN
Firm FEI
1045834
Firm city
Palm Beach Gardens
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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