The Recall Desk

FDA (Devices) recall action 65513

Zimmer, Inc. recalled 5 products on 2013-09-04

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2013-09-04
Critical
0
Units
—

Why these products were recalled

Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

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

States named across these recalls

1–5 of 5

  • HighFDA (Devices)··2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling Versa-FX II Femoral Fixation System units because a packaging configuration failed a leak test, compromising sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-1
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Recalled for Sterility Failure

    Zimmer, Inc. is recalling Free Lock Femoral Hip Fixation System Compression Tubes/Plates because a packaging configuration failed a leak test, compromising product sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Tube/Plate, different length (59, 75, 91, 107, 123 mm), holes (2, 3, 4, 5, 6) and degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-1181-130, 00-1181-135, 00-1181-140, 00-1181-145, 00-1181-150). ZIMMER Co
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-09-04

    Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall

    Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.

    Product
    Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2013-09-04

    Zimmer Recalls VERSA-FX Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling VERSA-FX Femoral Fixation System compression lag screws because a packaging failure compromised sterility. The recall affects 85,794 units distributed worldwide.

    Product
    VERSA-FX FEMORAL FIXATION SYSTEM COMPRESSION LAG SCREW, several length (55 mm to 155 mm), diameters (12.7 mm and 15.8 mm) and short thread, standard thread and large thread. Item codes starting with 00-1193-005, 00-1193-010 and 00-1193-015. orthopedic implant.
    Category
    Distribution
    1 state