Reported Nov 7, 2018 · Terminated
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated…
Zimmer Biomet, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
- Lot codes and dates
- Item # 10-1398W - SpF Plus - Mini 60/W
- Serial Numbers409180, 409203, 409209, 409462, 409468, 409474, 409687, 409755, 409760, 409175, 409181, 409204, 409437, 409463, 409469, 409475, 409688, 409756, 409754, 409176, 409182, 409205, 409438, 409464, 409470, 409476, 409751, 409757, 409686, 409177, 409200, 409206, 409439, 409465, 409471, 409684, 409752, 409758, 409473, 409178, 409201, 409207, 409440, 409466, 409472, 409685, 409753, 409759, 409467, 409179, 409202, 409208, and 409441 Item # 10-1398M - SpFPlus - Mini 60/M
- Serial Numbers408491, 408743, 408995, 409272, 409544, 409809, 410069, 408490, 408463, 408239, 408492, 408744, 408996, 409273, 409545, 409810, 410070, 408467, 408464, 408240, 408493, 408745, 408997, 409274, 409546, 409811, 410071, 408468, 408465,Item # 10-1335W - SpF - XL IIB 2/DW
1,824 of 1,824 codes
408241408494408746408998409275409547409812410072408469408466408242408495408747408999409276409548409813410073408470408716408243408496408748409001409277409549409814410074408471408717408244408497408749409002409278409550409815410075408472408718408245408498408750409003409279409551409816410076408473408719408246408499408751409004409280409552409817410077408474408967
- Serial Numbersand Item # 10-1335M -
218 of 218 codes
222960223185223331223455223610224090224204224295224536222717222961223186223332223456223611224091224205224296224537222718222962223187223333223457223612224092224206224508224538222719222963223188223334223458223614224093224207224510224539222720223150223190223377223459223615224094224208224511224540222721223151223191223378223460223616224095224210224512224541222722
- SpF - XL IIB 2/DM Serial Numbers
1,259 of 1,259 codes
222872223057223266223487223688223866224043224264224458222677222873223058223267223488223689223867224044224265224459222678222874223059223268223489223690223868224045224266224460222679222875223060223269223490223691223869224046224267224461222680222876223061223270223496223692223870224047224268224462222681222877223062223271223497223693223871224048224269224463222682
- Amount recalled
- 4,879 units (2,982 units have been implanted and 537 have been scrapped)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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