Z-0556-2009

External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86...

Name: Z-0556-2009 External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86...
Creator: Sterilmed Inc
Published: 2008-08-08
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2008-08-08 / Terminated / root cause: packaging

FDA source

Sterilmed Inc began a recall of 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... on 2008-08-08. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0556-2009
Status: Terminated
Initiated: 2008-08-08
Posted: 2009-01-13
Terminated: 2011-04-26
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 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
Product codes and lots: n/a

Product code KTT

K051957Class IIReprocessed External Fixation DeviceSterilemed, Inc. / cleared 2005-09-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)