FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
- Recall number
- Z-0695-2013
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
- Status
- Terminated
- Initiated
- 2012-10-25
- Posted
- 2013-01-17
- Terminated
- 2015-12-01
- Reason
- Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
- Root cause
- Device Design
- Action
- Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service.
- Quantity
- 476 units
- Distribution
- Nationwide Distribution, including the states of PA, OH, NY, CA and IL.
- Lot, serial or model codes
- Catalog number 4933-1-001, Lot number Z02804, Z08348, Z08350, Z12549, Z16753. Catalog number 4933-1-002, Lot number Z08351, Z12554, Z16246, Z16752. Catalog number 4933-1-003 Lot Number Z08349, Z09344, Z12551, Z16996.
- 510(k) numbers
- ["K113327"]
- PMA numbers
- not on file
- Product code
- KTT
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- 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