Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
Brand
Warsaw Orthopedic, Inc.
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Warsaw Orthopedic, Inc. is recalling Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. due to The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
Recommended Action
Per FDA guidance
Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026