FDA Medical Device Recalls (openFDA)
Surgical Specialties Corp: Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
- Recall number
- Z-0705-03
- Recalling firm
- Surgical Specialties Corp
- Product
- Sharpoint ClearTrap Trapezoid Clear Corneal/Implant Knife. Ophthalmic Knife 2.5 mm x 3.5 mm.
- Status
- Terminated
- Initiated
- 2003-01-07
- Posted
- 2003-04-01
- Terminated
- 2003-03-31
- Reason
- size mislabeled on product handle
- Root cause
- Other
- Action
- On 1/7/03, one account was contacted via telephone. On 1/10/03, a recall letter was faxed to that account. On 3/11/03, this wholesale account was asked to contact a hospital sub account that received a direct shipment. The other account was the complainant and telephone communications were occurring.
- Quantity
- 635 units
- Distribution
- The product was shipped to 2 wholesale accounts in PA and LA.
- Lot, serial or model codes
- Model # 75-2525, Lot #M118200
- 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
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