Food, drugs, devices › Exactech, Inc.
Device recall: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral st
FDA enforcement event 74317 is a device recall by Exactech, Inc. of Gainesville, FL, initiated 26 May 2016 and classified Class II, with 2 product records.
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 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 26 Jul 2019. 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
"Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another."
Distribution
"Nationwide Distribuiton to OK, ME, NY, & Hawaii."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2127-2016 | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative… | 8 units | Class II | Terminated | 13 Jul 2016 |
| Z-2128-2016 | Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the… | 14 | Class II | Terminated | 13 Jul 2016 |
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: "Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another."
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: "Nationwide Distribuiton to OK, ME, NY, & Hawaii."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Jul 2019. "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.