FDA Medical Device Recalls (openFDA)
Sterilmed Inc: External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation.
- Recall number
- Z-0556-2009
- Recalling firm
- Sterilmed Inc
- Product
- External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86 Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation.
- Status
- Terminated
- Initiated
- 2008-08-08
- Posted
- 2009-01-13
- Terminated
- 2011-04-26
- Reason
- SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. A breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable
- Root cause
- Packaging process control
- Action
- Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.
- Quantity
- 15
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
- Lot, serial or model codes
- n/a
- 510(k) numbers
- ["K051957"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3001237663
- Firm city
- Osseo
- Firm state
- MN
- 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