FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
- Recall number
- Z-0991-2009
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-02. The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
- Status
- Terminated
- Initiated
- 2008-12-19
- Posted
- 2009-02-27
- Terminated
- 2009-12-22
- Reason
- The c-clip located near the connection end may fracture or fall off during use in surgical procedures.
- Root cause
- Labeling design
- Action
- U.S. consignees were notified by "Urgent: Device Recall" letter issued via e-mail on December 19, 2008. The letter described the problem and instructed customers to immediately quarantine and return the recalled product along with the completed Inventory Return Certification form to the Zimmer, Inc. Distribution Center. Consignees were also instructed to fax a copy of the completed Inventory Return Certification Form at 1-574-371-8603. International consignees were also notified, but Zimmer, Inc. will gather the instruments from those customers. Direct questions about the recall to Zimmer, Inc. at 1-800-613-6131.
- Quantity
- 1,461 of both products.
- Distribution
- Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
- Lot, serial or model codes
- Lot Numbers: 60244767, 60254985, 60270484, 60283990, 60291761, 60295682,60298345, 60327534, 60332316, 60337990, 60347614, 60363922, 60395585, 60406637, 60416986, 60453034, 60468964, 60482887, 60517611, 60688076 and 60810866.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- 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