Exact FDA event identifier

Event 73200

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: April 12, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Exactech, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

Z-1900-2016

Recall number: Z-1900-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

device · product 2 of 6

Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.

Z-1901-2016

Recall number: Z-1901-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 2 devices.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

device · product 3 of 6

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.

Z-1902-2016

Recall number: Z-1902-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 4 devices.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-00-13, Serial Numbers: 4333544, 4333545, 4333546, Exp.3/22/2021 and Serial Number 4335281, Exp. 3/23/2021.

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

device · product 4 of 6

Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.

Z-1903-2016

Recall number: Z-1903-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 1 device.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-00-14, Serial Number: 4252802, Exp. 1/25/2021.

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

device · product 5 of 6

Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.

Z-1904-2016

Recall number: Z-1904-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 1 device.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021.

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

device · product 6 of 6

Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.

Z-1905-2016

Recall number: Z-1905-2016
Initiated: April 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: Exactech, Inc.
Quantity: 9 devices.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

Code information

Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.

Distribution pattern

Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.