Z-2552-2014Class II

Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT...

Name: Z-2552-2014 Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT...
Creator: Zimmer, Inc.
Published: 2014-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST... on 2014-07-22. FDA classified it as Class II and gives the reason as "Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2552-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-08-26
Terminated: 2015-09-15
Recalling firm: Zimmer GmbH
Product: Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMDX130MM CEMENTED STEM EXT 13MM X 145MM IMPACTOR SLEEVE* NGK STEM EXT 12X245MM (200MM) NGK STEM EXT 13X245MM (200MM) NGK STEM EXT 14X245MM (200MM) NGK STEM EXT 15X245MM (200MM) NGK STEM EXT 16X245MM (200MM) NGK STEM EXT 17X245MM (200MM) NGK STEM EXT 18X245MM (200MM) NGK STEM EXT 20X245MM (200MM) NGK STEM EXT 22X245MM (200MM) SMOOTH REV STM 9.5MM X 19 SMOOTH REV STM 11.5MM X 1 SMOOTH REV STM 13.5MM X 1 SMOOTH REV STM 15.5MM X 1 SMOOTH REV STM 17.5MM X 1 REV FEM STM 10.5MM X 200M REV FEM STM 12.5MM X 200M REV FEM STM 14.5MM X 200M REV FEM STM 16.5MM X 200M 18.5X200MM REV STEM REV FEM STM 10.5MM X 250M REV FEM STM 12.5MM X 250M REV FEM STM 14.5MM X 250M REV FEM STM 16.5MM X 250M 12.5X155MM FLUTED OFFST R 14.5X155MM FLUTED OFFST R 16.5X155MM FLUTED OFFST R 18.5X155MM FLUTED OFFST R 20.5X155MM FLUTED OFFST R 12.5X175MM FLUTED REV STM FLUTE REV STEM - 14.5MM X FLUTE REV STEM - 16.5MM X FLUTE REV STEM - 18.5MM X FLUTE REV STEM - 20.5MM X FLUTE REV STEM - 22.5MM X FLUTED REV STM 10.5MM X 1 FLUTED REV STM 11.5MM X 1 FLUTED REV STM 12.5MM X 1 FLUTED REV STM 13.5MM X 1 FLUTED REV STM 14.5MM X 1 FLUTED REV STM 16.5MM X 1 FLUTED REV STM 18.5MM X 1
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in commerce: 972,125 units
Distribution: Worldwide Distribution.
Product codes and lots: Item Numbers:00598801020, 00598801022, 00598801024, 00598801520, 00598801522, 00598801524, 00598801620, 00598801622, 00598801624, 00598801913, 31810604200, 32598801212, 32598801213, 32598801214, 32598801215, 32598801216, 32598801217, 32598801218, 32598801220, 32598801222, 621519095, 621519115, 621519135, 621519155, 621519175, 621520105, 621520125, 621520145, 621520165, 621520185, 621525105, 621525125, 621525145, 621525165, 681515125, 681515145, 681515165, 681515185, 681515205, 681517125, 681517145, 681517165, 681517185, 681517205, 681517225, 681519105, 681519115, 681519125, 681519135, 681519145, 681519165, 681519185 EXPIRATION DATE PRIOR TO 2024-07

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2552-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2547-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2548-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2549-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2550-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2551-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26
Z-2552-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-03	2014-08-26

Product code JWH

K933785Class IINext Generation Knee SystemZimmer, Inc. / cleared 1995-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)