Device recall: Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT

Class II FDA enforcement event 67503. Recall start date: 25 Feb 2014. Status in the FDA record: Terminated. Termination date: 24 Mar 2015.

Reason for recall, in the words of FDA

A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.

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 25 Feb 2014. The firm address in the FDA record is in Warsaw, IN. FDA put the recall in Class II. FDA event 67503 has 15 product records. The first FDA enforcement report date is 26 Mar 2014. The record gives the status Terminated, with the termination date 24 Mar 2015.

FDA enforcement report The 15 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-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI,…

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

15 product records in the event.

FDA event 67503: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1248-2014	Gender Solutions" Natural-Knee Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT	3638 units	Class II	Terminated	26 Mar 2014
Z-1249-2014	Natural-Knee N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1	3638 units	Class II	Terminated	26 Mar 2014
Z-1250-2014	MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM	3638 units	Class II	Terminated	26 Mar 2014
Z-1251-2014	Natural-Knee II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U	3638 units	Class II	Terminated	26 Mar 2014
Z-1252-2014	Natural-Knee II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm	3638 units	Class II	Terminated	26 Mar 2014
Z-1253-2014	Natural-Knee/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE	3638 units	Class II	Terminated	26 Mar 2014
Z-1254-2014	Natural-Knee Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5	3638 units	Class II	Terminated	26 Mar 2014
Z-1255-2014	Natural-Knee II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT…	3638 units	Class II	Terminated	26 Mar 2014
Z-1256-2014	Natural-Knee II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS…	3638 units	Class II	Terminated	26 Mar 2014
Z-1257-2014	Natural-Knee II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS…	3638 units	Class II	Terminated	26 Mar 2014
Z-1258-2014	Apollo" Knee System: APOLLO PATELLA SZ0 28MM R	3638 units	Class II	Terminated	26 Mar 2014
Z-1259-2014	Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO	3638 units	Class II	Terminated	26 Mar 2014
Z-1260-2014	Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS…	3638 units	Class II	Terminated	26 Mar 2014
Z-1261-2014	Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK…	3638 units	Class II	Terminated	26 Mar 2014
Z-1262-2014	Natural-Knee II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL…	3638 units	Class II	Terminated	26 Mar 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: 15Median 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-1248-2014The 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 67503. https://recallregister.com/fda/ii/67503/. 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-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI,…
What quantity of product is in FDA event 67503?: The event has 15 product records. The first record gives this quantity: 3638 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.