Food, drugs, devices › Exactech, Inc.
Device recall: NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be impla
FDA enforcement event 68341 is a device recall by Exactech, Inc. of Gainesville, FL, initiated 7 Mar 2014 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 4 Aug 2014. Initiation: voluntary: firm initiated. Exactech, Inc. has 61 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Exactech, Inc., Gainesville, FL.
Reason for recall
"The femoral stem is lacking specified plasma coating."
Distribution
"Worldwide Distribution including Spain, Greece and Japan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2086-2014 | 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. | 10 | Class II | Terminated | 30 Jul 2014 |
Context
Other enforcement events for Exactech, Inc.
All 61 events for Exactech, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The femoral stem is lacking specified plasma coating."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution including Spain, Greece and Japan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 4 Aug 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.