RecallRadar

FDA Device recall Z-0130-2014

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168

On 2013-11-13 the FDA classified a Class II recall of GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168 by Smith And Nephew, citing swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0130-2014
ClassificationClass II
Statusterminated
Initiated2013-10-07
Published2013-11-13
Last updated2026-09-13 11:53 UTC
CompanySmith And Nephew
DistributionUS

Product

GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic

Reason

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Identifiers

code_infoBatch No. 13GM11272

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0130-2014%22

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