RecallRadar

FDA Device recall Z-2086-2014

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit

On 2014-07-30 the FDA classified a Class II recall of NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit by Exactech, citing the femoral stem is lacking specified plasma coating.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2086-2014
ClassificationClass II
Statusterminated
Initiated2014-03-07
Published2014-07-30
Last updated2026-09-13 11:53 UTC
CompanyExactech
Distributionn/a

Product

NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.

Reason

The femoral stem is lacking specified plasma coating.

Identifiers

code_infoSerial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252

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-2086-2014%22

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