Device recall: Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM

Class II FDA enforcement event 68818. Recall start date: 22 Jul 2014. Status in the FDA record: Terminated. Termination date: 15 Sep 2015.

Reason for recall, in the words of FDA

Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.

Class II, in the words of FDA

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

Zimmer, Inc. started this device recall on 22 Jul 2014. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 68818 has 7 product records. The first FDA enforcement report date is 3 Sep 2014. The record gives the status Terminated, with the termination date 15 Sep 2015.

FDA enforcement report The 7 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution.

Recalling firm

Zimmer, Inc., Warsaw, IN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

7 product records in the event.

FDA event 68818: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2546-2014	Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM	972,125 units	Class II	Terminated	3 Sep 2014
Z-2547-2014	Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM DIA ENDO FEMORAL HEAD 50MM DIA ENDO FEMORAL HEAD…	972,125 units	Class II	Terminated	3 Sep 2014
Z-2548-2014	Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 43MM DIA, ENDO…	972,125 units	Class II	Terminated	3 Sep 2014
Z-2549-2014	Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0MMX115MMLG CANN BONE SCREW…	972,125 units	Class II	Terminated	3 Sep 2014
Z-2550-2014	Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SCP PLT 135DX8H TUBE&SCP PLT 135DX10H TUBE&SCP PLT…	972,125 units	Class II	Terminated	3 Sep 2014
Z-2551-2014	Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST FNSTRD HIP 50HDX152ST FNSTRD HIP 51HDX152ST…	972,125 units	Class II	Terminated	3 Sep 2014
Z-2552-2014	Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR…	972,125 units	Class II	Terminated	3 Sep 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class II: 91%
Product records in this event: 7Median of the firm: 1
Events of the firm on the register: 108

Other events of the firm

Other FDA enforcement events of Zimmer, Inc.
Initiated	Product (first record)	Type	Class	Records
20 May 2026	Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240	Device	Class II	5
11 May 2026	Brand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral Distal Augment Model/Catalog Number	Device	Class II	1
30 Mar 2026	Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011	Device	Class II	1
2 Dec 2025	Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number:	Device	Class II	17
26 Sep 2025	Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Ca	Device	Class II	2
24 Mar 2025	Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constr	Device	Class II	5
27 Feb 2025	NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number	Device	Class II	1
12 Feb 2025	Z1 Femoral Hip System, Product Number 611777612	Device	Class II	1
6 Jan 2025	NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm, Item Number 00-5994-022-14	Device	Class II	2
17 Sep 2024	Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access fo	Device	Class II	1

Zimmer, Inc.: all 108 events

Official channels

FDA enforcement report Z-2546-2014The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 68818. https://recallregister.com/fda/ii/68818/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution.
What quantity of product is in FDA event 68818?: The event has 7 product records. The first record gives this quantity: 972,125 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.