Recall Z-0695-2013— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-0695-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-25

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-10-25, terminated 2015-12-01. It names one FDA 510(k) clearance: K113327. Product: Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.. Reason: Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-10-25
Terminated: 2015-12-01
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K113327 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMStryker Corp.·cleared 2012-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.