Device recall: Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component…

Class II FDA enforcement event 72729. Recall start date: 2 Dec 2015. Status in the FDA record: Terminated. Termination date: 16 Sep 2016.

Reason for recall, in the words of FDA

Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on the inner package of P/N:00-5980-037-01 unit from lot #62460264

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 Manufacturing B.V. started this device recall on 2 Dec 2015. The firm address in the FDA record is in Mercedita, PR. FDA put the recall in Class II. FDA event 72729 has 1 product record. The first FDA enforcement report date is 30 Dec 2015. The record gives the status Terminated, with the termination date 16 Sep 2016.

FDA enforcement report The 1 product record

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.

US Distribution and the country of Thailand.

Recalling firm

Zimmer Manufacturing B.V., Mercedita, PR.

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

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

Products

1 product record in the event.

FDA event 72729: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0449-2016	Label reading in part as: "NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3; Lot Number:62460264. Indicated for patients with severe knee pain and disability and is intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum…	179	Class II	Terminated	30 Dec 2015

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 2015: 1,153
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of Zimmer Manufacturing B.V.
Initiated	Product (first record)	Type	Class	Records
4 May 2016	Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 3.5 mm Cortical Screw SelfTap	Device	Class II	12
17 Mar 2016	Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in to	Device	Class II	2
11 Jan 2016	Product 1 consists of all product under , product code: JWH and same usage: Item no: 47481500601 1.5 X 6 CORT SCREW HEX/	Device	Class II	72
3 Dec 2015	NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and REF 5986-37-01 Nonaugmentable Tibial Component	Device	Class II	1
4 Dec 2014	Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or unc	Device	Class II	1
21 Nov 2014	Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The mu	Device	Class II	1
12 Jun 2014	Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and	Device	Class II	1

Zimmer Manufacturing B.V.: all 8 events

Official channels

FDA enforcement report Z-0449-2016The 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.

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Cite this page

Recall Register. FDA enforcement event 72729. https://recallregister.com/fda/ii/72729/. 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: US Distribution and the country of Thailand.
What quantity of product is in FDA event 72729?: The FDA record gives this quantity: 179
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2015 have the same class?: 91% of the 1,153 device events that started in 2015 are in Class II.