Recalls / —

—#114929

Product

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

FDA product code

KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Device class

Class 2

Medical specialty

Orthopedic

510(k) numbers

K113327

Affected lot / code info

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.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm

Stryker Howmedica Osteonics Corp.

Address

325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern

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

Timeline

Recall initiated

2012-10-25

Posted by FDA

2013-01-17

Terminated

2015-12-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #114929. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.