Recall Z-0816-2016— Smith & Nephew, Inc.

Name: FDA recall Z-0816-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-18

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2016-01-18, terminated 2016-05-25. It names one FDA 510(k) clearance: K043440. Product: LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.. Reason: The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-18
Terminated: 2016-05-25
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K043440 — SMITH & NEPHEW, INC. REVISION KNEE SYSTEMSmith & Nephew, Inc.·cleared 2005-02-18

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

LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.

Reason for recall

The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws packaged with the wedge were too long.

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