FDA Medical Device Recalls (openFDA)
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 number
- Z-0198-2010
- Recalling firm
- Zimmer Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-08-03
- Posted
- 2009-11-13
- Terminated
- 2009-12-15
- Reason
- Manufacturing material may be present on the surface of the implant.
- Root cause
- Manufacturing material removal
- Action
- 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.
- Quantity
- 104
- Distribution
- Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.
- Lot, serial or model codes
- Lot 60378581.
- 510(k) numbers
- ["K953337"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28