Recall Z-1317-2014— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-1317-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-03

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2014-02-03, terminated 2014-12-02. It names one FDA 510(k) clearance: K993768. Product: Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.. Reason: Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-02-03
Terminated: 2014-12-02
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K993768 — CITATION TMZF HA STEMHowmedica Osteonics Corp.·cleared 2000-01-21

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

Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.

Reason for recall

Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.

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