Date Initiated by Firm |
August 15, 2019 |
Create Date |
September 12, 2019 |
Recall Status1 |
Terminated 3 on April 16, 2021 |
Recall Number |
Z-2526-2019 |
Recall Event ID |
83594 |
510(K)Number |
K132873
|
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product |
XP-XP Tibial Tray - Interlok 63 mm Item # 195751
|
Code Information |
Lot Number 522520 571140 589700 758150 028960 028980 043970 028980R 043970R 064960 028970 065200 101860 101880 065200R 433940 321620 321640 321620R 321640R 433910 592120 592140 592150 592170 257970 592180 801960 282710 282710R 282690 801940 801950 783060 783040 011410 975550 592110 984660 023340 257960 840190 061310 592160 102990 223050 261130 336080 585400 585370 511430 467140 684820 664140 634080 705510 715730 716030 716030R 920550 881940 029210 906640 985880 072790 125870 162880 396240 318430 247250 336660 441870 374320 587220 509590 543180 543150 708390 576080 639600 670510 522580 558990 593560 450400 741460 758480 780160 808130 833150 873470 943480 850880 917590 183370 560280 570170 570180 570180R 076640 191080 111620 950910 963430 999270 018060 261910 613310 650370 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact |
411 Technical Services 574-371-3071
|
Manufacturer Reason for Recall |
The locking bar not fully engaging
|
FDA Determined Cause 2 |
Manufacturing material removal |
Action |
Risk Manager Responsibilities:
1.Review this notification and ensure that affected personnel are aware of the contents.
2.If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
3.Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form will be returned even if you do not have affected products at your facility.
4.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
5.If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Surgeon Responsibilities:
1.Review this notification for awareness of the contents.
2.There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule.
3.A visual and audible confirmation should be made to ensure complete locking bar insertion.
4.Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.
5.Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation.
6.If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on- |
Quantity in Commerce |
480 units |
Distribution |
State
NY
IN
OH
MI
GA
SC
FL
MO
WI
MN
ND
SD
NE
NJ
PA
MD
IL
IA
CA
VA
NC
DC
WV
AR
AL
MS
AL
MI
WA
OR
ID
LA
FL
KS
TN
MA
KY
OK
TX
TX
CT
AZ
NV
NM
MT
WY
CO
UT
DC
WY
Country:
KOREA
CHINA
CANADA
AUSTRALIA
JAPAN
EMEA
SWEDEN
ITALY |
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 = BIOMET, INC.
|