Zimmer Inc. Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot 60947164.
Products Sold
Lot 60947164.
Zimmer Inc. is recalling Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, due to Some of the devices may possess a taper which will not mate with the humeral head, as intended.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
Recommended Action
Per FDA guidance
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.
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