| | Class 2 Device Recall Precice System |  |
| Date Initiated by Firm | February 12, 2021 |
|---|
| Date Posted | April 05, 2021 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1350-2021 |
|---|
| Recall Event ID |
87353 |
| 510(K)Number | K113695 |
|---|
| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
| Product | NUVASIVE PRECICE UNYTE System (Humerus and Tibia):
PRECICE Trauma Nail System/PRECICE Unyte-Humerus
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 165 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 180 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 195 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 210 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 225 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 240 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 255 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 270 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 285 mm length;
Orthopedic trauma intramedullary rod, humerus, 8.5 mm diameter, 300 mm length;
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 0mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 2mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 5mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 10mm);
End Cap for PRECICE Trauma Intramedullary Nail System Implant (humeral nail, 15mm);
3.5 mm Locking Screw, 20 mm Length;
3.5 mm Locking Screw 25 mm Length;
3.5 mm Locking Screw 30 mm Length;
3.5 mm Locking Screw 35 mm Length;
3.5 mm Locking Screw 40 mm Length;
3.5 mm Locking Screw 45 mm Length;
3.5 mm Locking Screw 50 mm Length;
3.5 mm Locking Screw 55 mm Length;
3.5 mm Locking Screw 60 mm Length;
Locking Screw, 3.5x65mm;
Locking Screw, 3.5x70mm;
Locking Screw, 3.5x75mm;
5.0 mm Locking Screw 20 mm Length;
5.0 mm Locking Screw 25 mm Length;
5.0 mm Locking Screw 30 mm Length;
5.0 mm Locking Screw 35 mm Length;
5.0 mm Locking Screw 40 mm Length;
5.0 mm Locking Screw 45 mm Length;
5.0 mm Locking Screw 50 mm Length;
5.0 mm Locking Screw 55 mm Length;
5.0 mm Locking Screw 60 mm Length;
5.0 mm Locking Screw 65 mm Length;
5.0 mm Locking Screw 70 mm Length;
5.0 mm Locking Screw 75 mm Length;
5.0 mm Locking Screw 20 mm Length;
5.0 mm Locking Screw 25 mm Length;
5.0 mm Locking Screw 30 mm Length;
5.0 mm Locking Screw 35 mm Length;
5.0 mm Locking Screw 40 mm Length;
5.0 mm Locking Screw 45 mm Length;
5.0 mm Locking Screw 50 mm Length;
5.0 mm Locking Screw 55 mm Length;
5.0 mm Locking Screw 60 mm Length;
5.0 mm Locking Screw 65 mm Length;
5.0 mm Locking Screw 70 mm Length;
5.0 mm Locking Screw 75 mm Length;
5.0 mm X 80 mm Locking Screw, Peg;
5.0 mm X 85 mm Locking Screw, Peg;
5.0 mm X 90 mm Locking Screw, Peg;
5.0 mm X 95 mm Locking Screw, Peg;
5.0 mm X 100 mm Locking Screw, Peg;
PRECICE Trauma Nail System/Precice Unyte-Tibia
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 240 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 255 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 270 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 285 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 300 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 315 mm length;
Orthopedic trauma intramedullary rod, antegrade tibia 10 degree bend, 11.5 mm diameter, 330 mm length;
Orthopedic trauma intra |
|---|
| Code Information |
All Lots manufactured between April 2015 to February 2021. PRECICE Unyte Product Codes (for Humerus): Trauma intramedullary rod, humerus, 8.5 mm diameter: CDH8.5-20L165; CDH8.5-20L180; CDH8.5-30L195; CDH8.5-50L210; CDH8.5-50M225; CDH8.5-50M240; CDH8.5-80M255; CDH8.5-80M270; CDH8.5-80M285; CDH8.5-80M300; end cap for trauma intramedullary humeral nail: HEC1-000; HEC2-000; HEC3-000; HEC4-000; HEC5-000; Locking screws: LSB3-020; LSB3-025; LSB3-030; LSB3-035; LSB3-040; LSB3-045; LSB3-050; LSB3-055; LSB3-060; LSB3-065; LSB3-070; LSB3-075; LSB5-020; LSB5-025; LSB5-030; LSB5-035; LSB5-040; LSB5-045; LSB5-050; LSB5-055; LSB5-060; LSB5-065; LSB5-070; LSB5-075; LSC5-020; LSC5-025; LSC5-030; LSC5-035; LSC5-040; LSC5-045; LSC5-050; LSC5-055; LSC5-060; LSC5-065; LSC5-070; LSC5-075; LSC5-080; LSC5-085; LSC5-090; LSC5-095; LSC5-100. GTIN Number (for Humerus): 00812258022730; 00812258022747; 00812258022754; 00812258022761; 00812258022778; 00812258022785; 00812258022792; 00812258022808; 00812258022815; 00812258022822; 00812258028121; 00812258028138; 00812258028145; 00812258028152; 00812258028169; 00812258021337; 00812258021344; 00812258021351; 00812258021368; 00812258021375; 00812258021382; 00812258021399; 00812258021405; 00812258021412; 00887517936233; 00887517936240; 00887517936257; 00856719002886; 00856719002893; 00856719002909; 00856719002916; 00856719002923; 00856719002930; 00856719002947; 00856719002954; 00856719002961; 00856719002978; 00856719002985; 00856719002992; 00812258021511; 00812258021528; 00812258021535; 00812258021542; 00812258021559; 00812258021566; 00812258021573; 00812258021580; 00812258021597; 00812258021603; 00812258021610; 00812258021627; 00887517001030; 00887517001047; 00887517001054; 00887517001061; 00887517001078; Precice Unyte Product Codes (for Tibia): trauma intramedullary rod, 11.5 mm diameter: CDT11.5-30T240; CDT11.5-30T255; CDT11.5-30T270; CDT11.5-30T285; CDT11.5-30T300; CDT11.5-30T315; CDT11.5-30T330; CDT11.5-30T345; CDT11.5-30T360; CDT11.5-30T375; CDT11.5C-30T240; CDT11.5C-30T255; CDT11.5C-30T270; CDT11.5C-30T285; CDT11.5C-30T300; CDT11.5C-30T315; CDT11.5C-30T330; CDT11.5C-30T345; CDT11.5C-30T360; CDT11.5C-30T375; trauma intramedullary rod, 12.5 mm diameter: CDT12.5-30T240; CDT12.5-30T255; CDT12.5-30T270; CDT12.5-30T285; CDT12.5-30T300; CDT12.5-30T315; CDT12.5-30T330; CDT12.5-30T345; CDT12.5-30T360; CDT12.5-30T375; CDT12.5C-30T240; CDT12.5C-30T255; CDT12.5C-30T270; CDT12.5C-30T285; CDT12.5C-30T300; CDT12.5C-30T315; CDT12.5C-30T330; CDT12.5C-30T345; CDT12.5C-30T360; CDT12.5C-30T375; end cap for trauma intramedullary nail: TEC1-000; TEC1-005; TEC1-010; TEC1-015; TEC1-020; Locking screws: TSA4.5-020; TSA4.5-025; TSA4.5-030; TSA4.5-035; TSA4.5-040; TSA4.5-045; TSA4.5-050; TSA4.5-055; TSA4.5-060; TSA4.5-065; TSA4.5-070; TSA4.5-075; TSA4-020; TSA4-022.5; TSA4-025; TSA4-027.5; TSA4-030; TSA4-032.5; TSA4-035; TSA4-037.5; TSA4-040; TSA4-042.5; TSA4-045; TSA4-047.5; TSA4-050; TSA4-055; TSA4-060; TSA4-065; TSA4-070; TSA4-075; TSA4-080; TSA4-085; TSA4-090; TSA4-095; TSA4-100; TSA4-100; TSA5-020; TSA5-020; TSA5-022.5; TSA5-022.5; TSA5-025; TSA5-025; TSA5-027.5; TSA5-027.5; TSA5-030; TSA5-030; TSA5-032.5; TSA5-032.5; TSA5-035; TSA5-035; TSA5-037.5; TSA5-037.5; TSA5-040; TSA5-040; TSA5-042.5; TSA5-042.5; TSA5-045; TSA5-045; TSA5-047.5; TSA5-047.5; TSA5-050; TSA5-050; TSA5-052.5; TSA5-055; TSA5-055; TSA5-057.5; TSA5-060; TSA5-060; TSA5-062.5; TSA5-065; TSA5-065; TSA5-067.5; TSA5-070; TSA5-070; TSA5-072.5; TSA5-075; TSA5-075; TSA5-080; TSA5-080; TSA5-085; TSA5-085; TSA5-090; TSA5-090; TSA5-095; TSA5-095; TSA5-100; TSA5-100; TSA5-105; TSA5-105; TSA5-110; TSA5-110. GTIN Number (for Tibia): 00812258027322; 00812258027339; 00812258027346; 00812258027353; 00812258027360; 00812258027377; 00812258027384; 00812258027391; 00812258027407; 00812258027414; 00812258027421; 00812258027438; 00812258027445; 00812258027452; 00812258027469; 00812258027476; 00812258027483; 00812258027490; 00812258027506; 00812258027513; 00812258027520; 00812258027537; 00812258027544; 00812258027551; 00812258027568; 00812258027575; 00812258027582; 00812258027599; 00812258027605; 00812258027612; 00812258027629; 00812258027636; 00812258027643; 00812258027650; 00812258027667; 00812258027674; 00812258027681; 00812258027698; 00812258027704; 00812258027711; 00812258028039; 00812258028046; 00812258028053; 00812258028060; 00812258028077; 00887517936011; 00887517936028; 00887517936035; 00887517936042; 00887517936059; 00887517936066; 00887517936073; 00887517936080; 00887517936097; 00887517936202; 00887517936219; 00887517936226; 00887517000033; 00887517000040; 00887517000057; 00887517000064; 00887517000071; 00887517000088; 00887517000095; 00887517000101; 00887517000118; 00887517000125; 00887517000132; 00887517000149; 00887517000156; 00887517000163; 00887517000170; 00887517000187; 00887517000194; 00887517000200; 00887517000217; 00887517000224; 00887517000231; 00887517000248; 00887517000255; 00887517000255; 00812258027728; 00887517000262; 00812258027735; 00887517000279; 00812258027742; 00887517000286; 00812258027759; 00887517000293; 00812258027766; 00887517000309; 00812258027773; 00887517000316; 00812258027780; 00887517000323; 00812258027797; 00887517000330; 00812258027803; 00887517000347; 00812258027810; 00887517000354; 00812258027827; 00887517000361; 00812258027834; 00887517000378; 00812258027841; 00887517000385; 00812258027858; 00812258027865; 00887517000392; 00812258027872; 00812258027889; 00887517000408; 00812258027896; 00812258027902; 00887517000415; 00812258027919; 00812258027926; 00887517000422; 00812258027933; 00812258027940; 00887517000439; 00812258027957; 00887517000446; 00812258027964; 00887517000453; 00812258027971; 00887517000460; 00812258027988; 00887517000477; 00812258027995; 00887517000484; 00812258028008; 00812258028008; 00812258028015; 00812258028015; Precice Unyte Product Codes (covers both Humerus and Tibia): trauma intramedullary rod, 10.7 mm diameter: T10.7-50A205; T10.7-50A225; T10.7-50A240; T10.7-50B205; T10.7-50B225; T10.7-50B240; T10.7-50C205; T10.7-50C225; T10.7-50C240; T10.7-50D205; T10.7-50D225; T10.7-50D240; T10.7-50E205; T10.7-50E225; T10.7-50E240; T10.7-80A255; T10.7-80A285; T10.7-80A315; T10.7-80A345; T10.7-80A375; T10.7-80B255; T10.7-80B285; T10.7-80B315; T10.7-80B345; T10.7-80B375; T10.7-80C255; T10.7-80C285; T10.7-80C315; T10.7-80C345; T10.7-80C375; T10.7-80D255; T10.7-80D285; T10.7-80D315; T10.7-80D345; T10.7-80D375; T10.7-80E255; T10.7-80E285; T10.7-80E315; T10.7-80E345; T10.7-80E375; trauma intramedullary rod, 12.5 mm diameter: T12.5-50A205; T12.5-50A225; T12.5-50A240; T12.5-50B205; T12.5-50B225; T12.5-50B240; T12.5-50C205; T12.5-50C225; T12.5-50C240; T12.5-50D205; T12.5-50D225; T12.5-50D240; T12.5-50E205; T12.5-50E225; T12.5-50E240; T12.5-80A255; T12.5-80A285; T12.5-80A315; T12.5-80A345; T12.5-80A375; T12.5-80B255; T12.5-80B285; T12.5-80B315; T12.5-80B345; T12.5-80B375; T12.5-80C255; T12.5-80C285; T12.5-80C315; T12.5-80C345; T12.5-80C375; T12.5-80D255; T12.5-80D285; T12.5-80D315; T12.5-80D345; T12.5-80D375; T12.5-80E255; T12.5-80E285; T12.5-80E315; T12.5-80E345; T12.5-80E375; trauma intramedullary rod, 8.5 mm diameter: T8.5-50A205; T8.5-50A225; T8.5-50A240; T8.5-50B205; T8.5-50B225; T8.5-50B240; T8.5-50C205; T8.5-50C225; T8.5-50C240; T8.5-50D205; T8.5-50D225; T8.5-50D240; T8.5-50E205; T8.5-50E225; T8.5-50E240; T8.5-80A255; T8.5-80A285; T8.5-80A315; T8.5-80A345; T8.5-80A375; T8.5-80B255; T8.5-80B285; T8.5-80B315; T8.5-80B345; T8.5-80B375; T8.5-80C255; T8.5-80C285; T8.5-80C315; T8.5-80C345; T8.5-80C375; T8.5-80D255; T8.5-80D285; T8.5-80D315; T8.5-80D345; T8.5-80D375; T8.5-80E255; T8.5-80E285; T8.5-80E315; T8.5-80E345; T8.5-80E375; GTIN Number (covers both Humerus and Tibia): 00812258023836; 00812258023843; 00812258023850; 00812258023119; 00812258023126; 00812258023133; 00812258023591; 00812258023607; 00812258023614; 00812258023355; 00812258023362; 00812258023379; 00812258024079; 00812258024086; 00812258024093; 00812258023867; 00812258023874; 00812258023881; 00812258023898; 00812258023904; 00812258023140; 00812258023157; 00812258023164; 00812258023171; 00812258023188; 00812258023621; 00812258023638; 00812258023645; 00812258023652; 00812258023669; 00812258023386; 00812258023393; 00812258023409; 00812258023416; 00812258023423; 00812258024109; 00812258024116; 00812258024123; 00812258024130; 00812258024147; 00812258023911; 00812258023928; 00812258023935; 00812258023195; 00812258023201; 00812258023218; 00812258023676; 00812258023683; 00812258023690; 00812258023430; 00812258023447; 00812258023454; 00812258024154; 00812258024161; 00812258024178; 00812258023942; 00812258023959; 00812258023966; 00812258023973; 00812258023980; 00812258023225; 00812258023232; 00812258023249; 00812258023256; 00812258023263; 00812258023706; 00812258023713; 00812258023720; 00812258023737; 00812258023744; 00812258023461; 00812258023478; 00812258023485; 00812258023492; 00812258023508; 00812258024185; 00812258024192; 00812258024208; 00812258024215; 00812258024222; 00812258023751; 00812258023768; 00812258023775; 00812258023034; 00812258023041; 00812258023058; 00812258023515; 00812258023522; 00812258023539; 00812258023270; 00812258023287; 00812258023294; 00812258023997; 00812258024000; 00812258024017; 00812258023782; 00812258023799; 00812258023805; 00812258023812; 00812258023829; 00812258023065; 00812258023072; 00812258023089; 00812258023096; 00812258023102; 00812258023546; 00812258023553; 00812258023560; 00812258023577; 00812258023584; 00812258023300; 00812258023317; 00812258023324; 00812258023331; 00812258023348; 00812258024024; 00812258024031; 00812258024048; 00812258024055; 00812258024062; |
| FEI Number |
3006179046
|
Recalling Firm/
Manufacturer |
Nuvasive Specialized Orthopedics Inc
101 Enterprise Ste 100
Aliso Viejo CA 92656-2604
|
Manufacturer Reason
for Recall | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. |
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FDA Determined
Cause 2 | Device Design |
|---|
| Action | On 02/11/2021, the firm started emailing an "URGENT FIELD SAFETY NOTICE" Notification to customers informing them that due to not having the full complement of biological assessments, the devices are not indicated for use in individuals under the age of 18 years old.
Customers are informed to:
-An Recalling Firm representative will be contacting your office or you to help with any questions or concerns.
-Review, complete, sign and return the attached Consignee Confirmation Form
accompanying this notification in accordance with the directions on the form.
-If a patient has been previously implanted with a listed device and was under the age of 18, consultation may be warranted, at the discretion of the provider.
-If a patient has been previously implanted with a listed device and is pregnant, becomes pregnant, or intends to become pregnant, consultation may be warranted, at the discretion of the provider.
-Forward this notice to anyone in your facility that needs to be informed.
-Direct any additional manufacturer inquiries to FSNprecice@nuvasive.com
-Report to NSO any adverse effect or product complaints related to the use of these devices to FSNprecice@nuvasive.com, whether or not those adverse effects are related to this FSN.
As a reminder, the following guidelines according to the Instructions for Use, including, but not limited to:
-The IFU should be consulted on an ongoing basis before and throughout patient
treatment with Precice products.
-These Precice family of devices are contraindicated in patients in which the Precice devices would cross joint spaces or open epiphyseal growth plates.
-These Precice family of devices are contraindicated in patients unwilling or incapable of following postoperative care instructions.
-Precice System devices should be removed after an implantation period of no more than one year.
-Once the physician determines that the Precice/Short/Freedom/Unyte System has achieved its intended use and is no longer requir |
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| Quantity in Commerce | 229 units |
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| Distribution | Worldwide distribution, including U.S. Nationwide. |
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| 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HSB
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