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Terminated

Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

FDA Recall Z-0695-2013 · Posted 2013-01-17

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKTT
Date Initiated2012-10-25
Date Terminated2015-12-01
Product Quantity476 units

Reason for Recall

Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution, including the states of PA, OH, NY, CA and IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113327HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMStryker Corp. · 2012-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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