Date Initiated by Firm | April 28, 2017 |
Create Date | June 15, 2017 |
Recall Status1 |
Terminated 3 on May 15, 2019 |
Recall Number | Z-2593-2017 |
Recall Event ID |
77141 |
510(K)Number | K830196 |
Product Classification |
Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
|
Product | VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H,
95DX20H, 95DX22H |
Code Information |
I10K: K954555,K150818 Item Numbers: 00119309016, 00119309516, 00119309518, 00119309520, 00119309522; Lot Numbers: 60746132 60746132R 60699481 60699481R 60812398 60812398R 60844072 60844072R 60820576 60868450 368893 368898 368898R 368917 368916 368899 61577082 61989416 370907 61895937 61895939 371034 62279718 62351559 62445941 62445942 62511278 62539606 37214360 37214354 37214361 37109128 37109081 62931489 62931529 62930529 63009490 63079560 63564928 63594628 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact | Customer Service 574-371-3071 |
Manufacturer Reason for Recall | Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package
configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents.
2. Immediately locate and quarantine affected product in your inventory.
3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form
a. Return a digital copy to corporatequality.postmarket@zimmerbiomet.com within three (3) days.
4. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. Additionally, Zimmer Biomet will also notify surgeons that have implanted the affected product within the past 12 months. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified.
5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks.
a. For each return, send a copy of Attachment 1 to corporatequality.postmarket@zimmerbiomet.com.
b. Include a |
Quantity in Commerce | 445 |
Distribution | Domestic: Puerto Rico, AK
AL
AR
AZ
CA
CO
CT
FL
GA
HI
IA
ID
IL
IN
KS
KY
LA
MA
MD
ME
MI
MN
MO
MS
MT
NC
ND
NE
NH
NJ
NM
NV
NY
OH
OK
OR
PA
RI
SC
SD
TN
TX
UT
VA
VT
WA
WI
WV
WY
Foreign: CANADA, ALGERIA
ARGENTINA
AUSTRALIA
BELGIUM
BRAZIL
BRIDGEND WALES
CHINA
DUBAI UAE
EGYPT
EL SALVADOR
ENGLAND
ESCHBACH GERMANY
EXPORT DORAL FL
FRANCE
GERMANY
GUATEMALA
HONDURAS
INDIA
ITALY
JAMAICA
JAPAN
JORDAN
KOREA
LEBANON
DELIVERY SERVICE (LYNBROOK NY)
MALAYSIA
MEXICO
MIAMI FL
MOROCCO
NETHERLANDS
NEW ZEALAND
NICARAGUA
PANAMA
PERU
PHARR TEXAS
POLAND
PUERTO RICO
RIO DE JANEIRO
SAUDI ARABIA
SINGAPORE
SPAIN
SWITZERLAND
TAIWAN
THAILAND
THE NETHERLANDS
TRIPOLI
UK
VIRGIN ISLANDS
VA/DOD: Both see addresses below |
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 = KTT
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