Date Initiated by Firm |
September 28, 2022 |
Date Posted |
November 11, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0200-2023 |
Recall Event ID |
90892 |
510(K)Number |
K111442
|
Product Classification |
Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
|
Product |
Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L, VLOCA208L, VLOCA304L, VLOCA306L, VLOCA308L. Automated suturing device. |
Code Information |
Model VLOCA004L
UDI-DI: 20884521068084
Lots
N1G0268Y
N9M0756Y
Model VLOCA006L
UDI-DI: 20884521068091
Lots
N0D0586Y
N0H0178Y
N1A0817Y
N1B0531Y
N1E0104Y
N1E0747Y
N1F0714Y
N1H0583Y
N1J0848Y
N2D0068Y
N2D0077Y
N2D0240Y
Model VLOCA008L
UDI-DI: 20884521068275
Lots
N0A0577Y
N0C0316Y
N0D0001Y
N0D0106Y
N0D0397Y
N0D0398Y
N0E0682Y
N0F0368Y
N0F0758Y
N0F0969Y
N0G0972Y
N0J1022Y
N0J1023Y
N0K0723Y
N0K1031Y
N0L0127Y
N0L0128Y
N0M0360Y
N0M0513Y
N1A0199Y
N1A0660Y
N1A0816Y
N1A0958Y
N1B0110Y
N1B0750Y
N1C0088Y
N1C0398Y
N1C0495Y
N1D0528Y
N1D0697Y
N1D0853Y
N1E0102Y
N1E0103Y
N1F0035Y
N1F0182Y
N1G0107Y
N1G0404Y
N1G0628Y
N1H0234Y
N1H0677Y
N1J0440Y
N1K0248Y
N1K0306Y
N1K0867Y
N1L0592Y
N1L0766Y
N1M0720Y
N1M0731Y
N2A0468Y
N2B0095Y
N2B0188Y
N2B0289Y
N2C0008Y
N2C0009Y
N2C0032Y
N2C0495Y
N2C0683Y
N2D0813Y
N2D0814Y
N9K1167Y
N9K1169Y
N9L0102Y
N9L0103Y
N9L0503Y
N9L0966Y
N9M0077Y
Model VLOCA204L
UDI-DI: 20884521068114
Lots
N0C0212Y
N0J0294Y
Model VLOCA206L
UDI-DI: 20884521068121
Lots
N0C0307Y
N0D0105Y
N0D0326Y
N0D0327Y
N0D0587Y
N0E0718Y
N0E0979Y
N1A0502Y
N1E0748Y
N1F0701Y
N1F0915Y
N1G0759Y
N1H0058Y
N1H0803Y
N1K0185Y
N1M0276Y
N2C0524Y
N2D0233Y
N2D0444Y
N2D0445Y
Model VLOCA208L
UDI-DI: 20884521068282
Lots N0A0201Y
N0C1103Y
N0D0498Y
N0D0506Y
N0F0759Y
N0G0279Y
N0G0280Y
N0H0960Y
N0K0671Y
N0K0672Y
N0M0315Y
N0M0393Y
N1A0156Y
N1A0501Y
N1B0084Y
N1B0263Y
N1B0560Y
N1C0728Y
N1E0462Y
N1E0508Y
N1F0048Y
N1F0556Y
N1G0123Y
N1G0442Y
N1H0056Y
N1H0257Y
N1H0666Y
N1H0901Y
N1J0216Y
N1J0510Y
N1J0850Y
N1K0164Y
N1L0069Y
N1L0494Y
N1L0672Y
N2A0110Y
N2B0148Y
N2E0299Y
N9K1182Y
N9L0093Y
N9L0502Y
N9L0737Y
N9L0738Y
N9L0761Y
N9M0758Y
Model VLOCA304L
UDI-DI: 20884521068138
Lots
N0B0409Y
N0D0405Y
N0F1041Y
N0J0293Y
Model VLOCA306L
UDI-DI: 20884521068152
Lots
N0A0239Y
N0A0527Y
N0F0833Y
N0H1087Y
N1F0811Y
N1G0287Y
N1G0763Y
N1K0247Y
N2B0322Y
N2C0682Y
N2D0302Y
N2D0552Y
N9J0258Y
N9M0757Y
Model VLOCA308L
UDI-DI: 20884521068787
Lots
N0A0383Y
N0K0988Y
N1G0106Y
N1G0551Y
N1L0085Y
N1L0162Y
N2C0509Y
|
Recalling Firm/ Manufacturer |
Covidien, LP 60 Middletown Ave North Haven CT 06473-3908
|
For Additional Information Contact |
Medtronic Customer Service 800-962-9888
|
Manufacturer Reason for Recall |
Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s) include a delay in treatment/therapy, the potential for a portion of the needle to remain in the patient, foreign body reaction, allergic reaction, tissue injury and unintended radiation exposure from additional imaging for both intra-op and postoperative scenarios.
|
FDA Determined Cause 2 |
Process control |
Action |
Beginning 28-September-2022 communications to all affected consignees
began.
Consignees are asked to return any affected product they may have,
forward this notification to those who need to be aware within the
organization and to any location which the devices have been transferred.
Consignees are asked to complete and return a confirmation certificate (or
equivalent record) confirming they have received the notification. |
Quantity in Commerce |
117978 |
Distribution |
Domestic distribution nationwide.
Foreign distribution to Australia
Austria
Belgium
Canada
Canary Islands
Chile
Croatia
Cyprus
Denmark
Egypt
Finland
France
Germany
Greece
Hungary
Ireland
Israel
Italy
Jordan
Kazakhstan
Kuwait
Lithuania
Luxembourg
Mexico
Netherlands
New Zealand
Norway
Poland
Portugal
Puerto Rico
Qatar
Reunion
Romania
Russian Federation
Saudi Arabia
Slovakia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom
|
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = GAM and Original Applicant = COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
|