FDA Medical Device Recalls (openFDA)
Ossur: Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS
- Recall number
- Z-0596-2009
- Recalling firm
- Ossur
- Product
- Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS
- Status
- Terminated
- Initiated
- 2008-09-26
- Posted
- 2009-01-02
- Terminated
- 2010-04-27
- Reason
- Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
- Root cause
- Packaging process control
- Action
- Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?
- Quantity
- 1 pouches (4 pins/pouch) = 4 pin
- Distribution
- Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
- Lot, serial or model codes
- Lot Number: 08060305
- 510(k) numbers
- ["K023959","K040363"]
- PMA numbers
- not on file
- Product code
- LYT
- Firm FEI
- 3003764610
- Firm city
- Reykjavik
- Firm state
- not on file
- Firm country
- Ireland
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