RecallRadar

FDA Device recall Z-2163-2018

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

On 2018-06-20 the FDA classified a Class II recall of smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) by Smith And Nephew, citing one lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2163-2018
ClassificationClass II
Statusterminated
Initiated2018-05-04
Published2018-06-20
Last updated2026-09-13 11:54 UTC
CompanySmith And Nephew
Distributionn/a

Product

smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)

Reason

One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.

Identifiers

code_info15FM16181

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2163-2018%22

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