| Date Initiated by Firm | September 30, 2024 |
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| Date Posted | November 21, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0500-2025 |
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| Recall Event ID |
95567 |
| 510(K)Number | K232267 |
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| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
| Product | Precice Max REF:
PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm
PM10.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 280mm
PM10.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 305mm
PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm
PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm
PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 265mm
PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 280mm
PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 10.0mm x 305mm
PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm
PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm
PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm
PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm
PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm
PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 265mm
PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 280mm
PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10 Bend 3 Hole 11.5mm x 305mm
PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm
PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm
PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm
The Precice Max Nail is intended to stabilize fractures, nonunions, and malunions of the femur, tibia, and humerus. In addition, the Precice Nail is intended to provide magnetically controlled lengthening of long bones and/or transporting of bone segments in the femur, tibia, and humerus. |
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| Code Information |
Part Number: PM10.0-80B265
UDI codes:
(01)00195377150929(11)240223(17)290131(10)4021504AAA
(01)00195377150929(11)240301(17)290228(10)4022214AAA
Lot Numbers:
4021504AAA
4022214AAA
Part Number: PM10.0-80B280
UDI codes:
(01)00195377151032(11)240222(17)290131(10)4021505AAA
(01)00195377151032(11)240220(17)290131(10)4021903AAA
Lot Numbers:
4021505AAA
4021903AAA
Part Number: PM10.0-80B305
UDI Codes:
(01)00195377151148(11)240214(17)290131(10)4021217AAA
(01)00195377151148(11)240220(17)290131(10)4021901AAA
(01)00195377151148(11)240304(17)290228(10)4022131AAA
Lot Numbers:
4021217AAA
4021901AAA
4022131AAA
PM10.0-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 335mm 4021218AAA (01)00195377151254(11)240215(17)290131(10)4021218AAA
4021910AAA (01)00195377151254(11)240221(17)290131(10)4021910AAA
4022301AAA (01)00195377151254(11)240304(17)290228(10)4022301AAA
4022625AAA (01)00195377151254(11)240301(17)290228(10)4022625AAA
PM10.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 365mm 4022135AAA (01)00195377151360(11)240304(17)290228(10)4022135AAA
4022136AAA (01)00195377151360(11)240223(17)290131(10)4022136AAA
PM10.0-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 265mm 4021307AAA (01)00195377150998(11)240219(17)290131(10)4021307AAA
4021926AAA (01)00195377150998(11)240221(17)290131(10)4021926AAA
PM10.0-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 280mm 4021314AAA (01)00195377151100(11)240215(17)290131(10)4021314AAA
4021602AAA (01)00195377151100(11)240223(17)290131(10)4021602AAA
4022005AAA (01)00195377151100(11)240222(17)290131(10)4022005AAA
PM10.0-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 10.0mm x 305mm 4021401AAA (01)00195377151216(11)240229(17)290131(10)4021401AAA
PM11.5-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 265mm 4021524AAA (01)00195377151698(11)240219(17)290131(10)4021524AAA
PM11.5-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 280mm 4021502AAA (01)00195377151803(11)240216(17)290131(10)4021502AAA
4021503AAA (01)00195377151803(11)240216(17)290131(10)4021503AAA
PM11.5-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 305mm 4021203AAA (01)00195377151919(11)240215(17)290131(10)4021203AAA
4021921AAA (01)00195377151919(11)240227(17)290131(10)4021921AAA
4022010AAA (01)00195377151919(11)240301(17)290228(10)4022010AAA
PM11.5-80B335 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 335mm 4021205AAA (01)00195377152022(11)240216(17)290131(10)4021205AAA
4021530AAA (01)00195377152022(11)240219(17)290131(10)4021530AAA
4022011AAA (01)00195377152022(11)240228(17)290131(10)4022011AAA
PM11.5-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 11.5mm x 365mm 4021902AAA (01)00195377152138(11)240222(17)290131(10)4021902AAA
PM11.5-80TJ265 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 265mm 4021404AAA (01)00195377151766(11)240221(17)290131(10)4021404AAA
PM11.5-80TJ280 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 280mm 4021501AAA (01)00195377151872(11)240219(17)290131(10)4021501AAA
4022626AAA (01)00195377151872(11)240304(17)290228(10)4022626AAA
PM11.5-80TJ305 PRECICE MAX Antegrade Tibia 10¿ Bend 3 Hole 11.5mm x 305mm 4021407AAA (01)00195377151988(11)240216(17)290131(10)4021407AAA
PM13.0-80B280 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 280mm 4021525AAA (01)00195377152572(11)240220(17)290131(10)4021525AAA
4022009AAA (01)00195377152572(11)240221(17)290131(10)4022009AAA
PM13.0-80B305 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 305mm 4022623AAA (01)00195377152688(11)240301(17)290228(10)4022623AAA
PM13.0-80B365 PRECICE MAX Antegrade Femur Piriformis Straight 13.0mm x 365mm 4022001AAA (01)00195377152909(11)240221(17)290131(10)4022001AAA
|
Recalling Firm/
Manufacturer |
NuVasive Specialized Orthopedics, Inc.
101 Enterprise Ste 100
Aliso Viejo CA 92656-2604
|
| For Additional Information Contact |
949-837-3600 Ext. 11 |
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Manufacturer Reason
for Recall | Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 9/30/2024, the firm sent an "URGENT: Medical Device Recall Notification" letter via FedEx to customers informing them that Globus Medical is investigating potential issues with the design, manufacturing, and documentation related to the validation associated with the Precice Max manufactured by NuVasive Specialized Orthopedics (NSO).
Customers are instructed to:
Monitor their patients closely for any potential adverse events and to stop/cease use of device that have not been implanted and immediately return all remaining Precice" Max devices and complete the attached Response Form and send it by FAX: 1-610-300-1342 or
Email:recall@globusmedical.com.
Contact Globus Customer Service at 1-866-456-2871 for Return Authorization. Contact your local Globus Sales Representative to coordinate the return of the Precice Max Device(s).
For recall related questions and support contact: Globus Medical Complaint Handling Unit by Fax: 610-300-1342 or Email: recall@globusmedical.com.
|
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| Quantity in Commerce | 164 devices |
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| Distribution | U.S distribution to states of: FL and NV.
|
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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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