Recall Z-0573-2016— Smith & Nephew, Inc.

Name: FDA recall Z-0573-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-09

Class II · Terminated

Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2015-11-09, terminated 2016-03-17. It names one FDA 510(k) clearance: K951987. Product: Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.. Reason: One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation..

Recalling firm: Smith & Nephew, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-11-09
Terminated: 2016-03-17
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K951987 — GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc.·cleared 1995-08-22

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

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

Reason for recall

One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

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