FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Recall number
- Z-2246-2014
- Recalling firm
- Zimmer, Inc.
- Product
- 6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
- Status
- Terminated
- Initiated
- 2014-07-22
- Posted
- 2014-08-16
- Terminated
- 2015-06-18
- Reason
- Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Root cause
- Package design/selection
- Action
- On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
- Quantity
- 47,682 units total
- Distribution
- National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
- Lot, serial or model codes
- Item Number 47-4865-020, 025, 030-00
- 510(k) numbers
- ["K112885"]
- PMA numbers
- not on file
- Product code
- HWC
- 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