Date Initiated by Firm | August 15, 2019 |
Create Date | September 12, 2019 |
Recall Status1 |
Terminated 3 on April 16, 2021 |
Recall Number | Z-2508-2019 |
Recall Event ID |
83594 |
510(K)Number | K132873 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | XP-CR Tibial Tray - Interlok 71mm
Item # 195273 |
Code Information |
Lot Number 663640 262420 571030 590700 590710 676280 917650 320580 966740 995980 996090 966740R 043890 159270 206840 258080 283210 841530 043900 066200 090220 066200R 322070 322070R 383700 352840 283180 359640 322090 429260 374800 403830 159260 456770 041150 579240 899740 274590 274530 274580 041240 041190 503440 585580 993810 666890 503460 888430 221170 985320 374080 374070 279030 599140 576020 943390 821310 411240 450350 600790 712570 717180 717180R 018020 111590 676310 676310R 072520 218650 291200 072520R 672570 289190 562280 148430 291190 351320 445400 445410 486120 445400R 445410R |
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 | 454 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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