Recall Z-1127-2013— Synvasive Technology Inc

Name: FDA recall Z-1127-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-14

Class II · Terminated

Class II FDA medical device recall by Synvasive Technology Inc, initiated 2013-03-14, terminated 2014-01-13. It names one FDA 510(k) clearance: K911902. Product: The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.. Reason: Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade..

Recalling firm: Synvasive Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-14
Terminated: 2014-01-13
Firm location: El Dorado Hills, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K911902 — TEMPERLITE(TM) SAW BLADESierra Surgical, Inc.·cleared 1991-06-28

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

The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.

Reason for recall

Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.

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