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Health product recall

Zimmer Packaged Implants (2017-05-09)

Starting date:
May 9, 2017
Posting date:
June 1, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-63428

Reason

Zimmer is initiating a field action for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the two configurations failed simulated distribution and shipping testing. The devices impacted are generally the heaviest outlier sizes within the respective product family.

Affected products

A. Versa Fx Femoral Fixation Tube Plates

Lot or serial number

All lots expiring before May 2027

Model or catalog number

  • 00-1193-130-16
  • 00-1193-135-16
  • 00-1193-135-18
  • 00-1193-135-20
  • 00-1193-140-16
  • 00-1193-145-16
  • 00-1193-150-16
  • 00-1193-150-18
  • 00-1193-150-20

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



B. Versa Fx Femoral Fixation Tube Plates

Lot or serial number

All lots expiring before May 2027

Model or catalog number

  • 00-1193-090-16
  • 00-1193-095-16
  • 00-1193-095-18
  • 00-1193-095-20
  • 00-1193-095-22

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



C. M/Dn Intramedullary Fixation System

Lot or serial number

All lots expiring before May 2027

Model or catalog number

00-2240-010-48

00-2240-011-42

00-2240-011-44

00-2240-011-46

00-2240-011-48

00-2240-012-46

00-2240-012-48

00-2240-013-40

00-2240-013-42

00-2240-013-44

00-2240-013-46

00-2240-013-48

00-2240-014-34

00-2240-014-36

00-2240-014-38

00-2240-014-40

00-2240-014-42

00-2240-014-44

00-2240-014-46

00-2240-014-48

00-2252-300-15

00-2252-300-16

00-2252-320-14

00-2252-320-15

00-2252-320-16

00-2252-340-14

00-2252-340-15

00-2252-340-16

00-2252-360-14

00-2252-360-15

00-2252-380-14

00-2252-380-15

00-2252-400-11

00-2252-400-13

00-2252-400-14

00-2252-400-15

00-2252-420-11

00-2252-420-12

00-2252-420-13

00-2252-420-14

00-2252-420-15

00-2252-440-11

00-2252-440-12

00-2252-440-13

00-2252-440-14

00-2252-460-10

00-2252-460-11

00-2252-460-12

00-2252-460-13

00-2252-460-14

00-2252-480-10

00-2252-480-11

00-2252-480-12

00-2252-480-13

00-2252-480-14

00-2252-500-13

00-2252-500-14

00-2253-260-15

00-2253-280-15

00-2253-300-15

00-2253-320-14

00-2253-320-15

00-2253-340-14

00-2253-340-15

00-2253-360-14

00-2253-360-15

00-2253-380-14

00-2253-380-15

00-2253-400-13

00-2253-400-14

00-2253-400-15

00-2253-420-13

00-2253-420-14

00-2253-420-15

00-2253-440-11

00-2253-440-13

00-2253-440-14

00-2253-460-11

00-2253-460-12

00-2253-460-13

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



D. Itst Femoral Nails

Lot or serial number

All lots expiring before May 2027

Model or catalog number

00-2257-300-04

00-2257-300-14

00-2257-320-03

00-2257-320-04

00-2257-320-13

00-2257-320-14

00-2257-340-01

00-2257-340-03

00-2257-340-04

00-2257-340-11

00-2257-340-13

00-2257-340-14

00-2257-360-01

00-2257-360-02

00-2257-360-03

00-2257-360-04

00-2257-360-11

00-2257-360-12

00-2257-360-13

00-2257-360-14

00-2257-380-00

00-2257-380-01

00-2257-380-02

00-2257-380-03

00-2257-380-04

00-2257-380-10

00-2257-380-11

00-2257-380-12

00-2257-380-13

00-2257-380-14

00-2257-400-00

00-2257-400-01

00-2257-400-02

00-2257-400-03

00-2257-400-04

00-2257-400-10

00-2257-400-11

00-2257-400-12

00-2257-400-13

00-2257-400-14

00-2257-420-00

00-2257-420-01

00-2257-420-02

00-2257-420-03

00-2257-420-04

00-2257-420-10

00-2257-420-11

00-2257-420-12

00-2257-420-13

00-2257-420-14

00-2257-440-00

00-2257-440-01

00-2257-440-02

00-2257-440-03

00-2257-440-04

00-2257-440-10

00-2257-440-11

00-2257-440-12

00-2257-440-13

00-2257-440-14

00-2257-460-00

00-2257-460-01

00-2257-460-02

00-2257-460-03

00-2257-460-04

00-2257-460-10

00-2257-460-11

00-2257-460-12

00-2257-460-13

00-2257-460-14

00-2257-480-00

00-2257-480-01

00-2257-480-02

00-2257-480-03

00-2257-480-10

00-2257-480-11

00-2257-480-12

00-2257-480-13

00-2257-500-00

00-2257-500-01

00-2257-500-02

00-2257-500-03

00-2257-500-10

00-2257-500-11

00-2257-500-12

00-2257-500-13

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



E. Zimmer Natural Nail System Tibial Nails

Lot or serial number

All lots expiring before May 2027

Model or catalog number

47249538014

47249540014

47249542014

47249544014

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES



F. Zimmer Natural Nail System Femoral Nail

Lot or serial number

All lots expiring before May 2027

Model or catalog number

47-2492-460-14

47-2492-461-14

Companies

Manufacturer

Zimmer Inc.

1800 West Center Street

Warsaw

46580

UNITED STATES


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