FDA Recall
Terminated
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Recall: Z-0177-2010
·
Initiated September 17, 2009
Recall
- Recall Number
- Z-0177-2010
- Event Number
- 53536
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- HSD
- Status
- Terminated
- Root Cause
- Other
- Initiated
- September 17, 2009
- Posted
- November 12, 2009
- Terminated
- December 22, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Reason
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Action
Zimmer distributors were notified by email on 9/19/09 to locate and return the products. Letter dated 9/29/09 were sent to the Zimmer salesforce and distributors with a letter to be given to each affected hospital account to inform them of the problem. Zimmer accounts were again asked to locate and return the devices. Hospital accounts were requested to consider the available facts when monitoring potentially affected patients.
Distribution
Nationwide.
Quantity
12