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FDA Medical Device Recalls (openFDA)

Surgical Specialties Corp: Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.

Recall number
Z-0026-04
Recalling firm
Surgical Specialties Corp
Product
Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Status
Terminated
Initiated
2003-08-21
Posted
2003-10-15
Terminated
2004-01-13
Reason
text on product handle is incorrect
Root cause
Other
Action
The consignees were notified via fax on 8/21/03. One customer received a recall letter via mail on 8/22/03.
Quantity
666 units
Distribution
The products were shipped to two hospitals in CA, two sales representatives in NC & IL, and three wholesalers in IL, Belgium, Canada, and Austrailia.
Lot, serial or model codes
M190500 exp 11/2007 and M203840 exp 12/2007
510(k) numbers
["K822112"]
PMA numbers
not on file
Product code
HNN
Firm FEI
2522801
Firm city
Reading
Firm state
PA
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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