| Date Initiated by Firm |
August 15, 2019 |
| Create Date |
September 12, 2019 |
| Recall Status1 |
Terminated 3 on April 16, 2021 |
| Recall Number |
Z-2515-2019 |
| Recall Event ID |
83594 |
| 510(K)Number |
K122160
|
| Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
| Product |
XP-CR Tibial Tray - Porous Plasma 91 mm
Item # 195291
|
| Code Information |
Lot Numbers 149710 615950 |
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 |
2 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 MANUFACTURING CORP.
|
