The Recall Desk

FDA (Devices) recall action 67503

Zimmer, Inc. recalled 15 products on 2014-03-26

The FDA (Devices) publishes a recall like this one as 15 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 15 pages.

Products
15
Announced
2014-03-26
Critical
0
Units
54,570

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–15 of 15

  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II Poly Ultra Tibia Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Poly Ultra Tibia components worldwide due to discoloration caused by premature oxidation during storage.

    Product
    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 UL
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II Constrained Knee System Tibia Components

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II Constrained Knee System tibia components due to discoloration caused by premature oxidation.

    Product
    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
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Apollo Revision Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Revision/Constrained Knee System tibia inserts because they were discolored due to premature oxidation during storage.

    Product
    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 I
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II Unicompartmental Knee System Components

    Zimmer, Inc. is recalling specific Natural-Knee II unicompartmental knee system tibia components due to discoloration caused by premature oxidation during storage.

    Product
    Natural-Knee¿ II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Apollo Knee Tibial Baseplates Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee Tibial Baseplates and Inserts because free radical oxidation caused discoloration in some units.

    Product
    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 S
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls MOST Options Hinged Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of MOST Options System hinged tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

    Product
    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
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee Congruent Tibial Inserts with Screws because a complaint identified discoloration caused by premature oxidation during storage.

    Product
    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
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II System components due to discoloration caused by premature oxidation. The affected devices were stored in transparent containers exposed to light.

    Product
    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 I
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee Flex System Components Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of the Natural-Knee Flex System due to discoloration caused by premature oxidation during storage.

    Product
    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
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Apollo Knee System Tibia Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Apollo Knee System tibia inserts because free radical oxidation caused discoloration. The issue resulted from improper storage conditions prior to packaging.

    Product
    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/
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee/Apollo Knee Implants Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee/Apollo knee implants because a component was discolored due to premature oxidation.

    Product
    Natural-Knee¿/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II Tibial Inserts Due to Discoloration

    Zimmer, Inc. is recalling 3,638 Natural-Knee II Posterior Stabilized Condylar Tibial Inserts because free radical oxidation caused discoloration.

    Product
    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 T
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee II Prosthesis Due to Discoloration

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee II knee prostheses because a component was found to be discolored due to premature oxidation.

    Product
    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 I
    Category
    Distribution
    32 states
  • ModerateFDA (Devices)··2014-03-26

    Zimmer Recalls Natural-Knee N-K II Domed All-Poly Pat Components

    Zimmer, Inc. is recalling 3,638 units of Natural-Knee N-K II Domed All-Poly Pat components due to discoloration caused by premature oxidation.

    Product
    Natural-Knee¿ N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1
    Category
    Distribution
    32 states