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U.S. Department of Health and Human Services

Class 2 Device Recall Knee Stem Extensions & Impactor Sleeve

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  Class 2 Device Recall Knee Stem Extensions & Impactor Sleeve see related information
Date Initiated by Firm July 22, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2552-2014
Recall Event ID 68818
510(K)Number K933785  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
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
Code Information 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
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ZIMMER, INC.
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