Zimmer Inc. Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lot 60378581.
Products Sold
Lot 60378581.
Zimmer Inc. is recalling Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, due to Manufacturing material may be present on the surface of the implant.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing material may be present on the surface of the implant.
Recommended Action
Per FDA guidance
An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A "Dear Surgeon" letter will be issued to any hospitals where the devices have been implanted.
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