Precice Bone Transport - Product Usage: intended for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Check against the official notice below — it lists the full affected range.
Nuvasive Specialized Orthopedics Inc. has recalled Precice Bone Transport devices used for limb lengthening, fracture fixation, and related orthopedic procedures. The recall affects 226 units across all lots of multiple product variants. The company received complaints of adverse events potentially related to biological safety, including reports of pain and bony abnormalities occurring at the interface between the telescoping nail segments.
The affected devices have been distributed worldwide, including throughout the United States and 29 additional countries. The recall encompasses various configurations of antegrade and retrograde femur and tibia devices in different sizes and lengths. The recall documentation does not specify what action affected consumers or patients should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.
Reason for recall: Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete cont Quantity: 226 units Lot/code info: All Lots affected. Below are: Primary DI Number(GTIN)/Product Code (REF)/Product Description: 887517981370 BT10-100C360-5 Antegrade Tibia 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981554 BT10-10A360-5 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 5/10cm ST; 887517981547 BT10-10A360-7 Retrograde Femur 10¿ Bend, 10.0mm x 360mm, 7/10cm ST; 887517981530 BT10-10A380-5 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 5/10cm ST; 887517981523 BT10-10A380-7 Retrograde Femur 10¿ Bend, 10.0mm x 380mm, 7/10cm ST; 887517981516 BT10-10A400-5 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 5/10cm ST; 887517981509 BT10-10A400-7 Retrograde Femur 10¿ Bend, 10.0mm x 400mm, 7/10cm ST; 887517981493 BT10-10B360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981486 BT10-10B360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981479 BT10-10B380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981462 BT10-10B380-7 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 7/10cm ST; 887517981455 BT10-10B400-5 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 5/10cm ST; 887517981448 BT10-10B400-7 Antegrade Femur Piriformis Straight, 10.0mm x 400mm, 7/10cm ST; 887517981431 BT10-10BT360-5 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 5/10cm ST; 887517981424 BT10-10BT360-7 Antegrade Femur Piriformis Straight, 10.0mm x 360mm, 7/10cm ST; 887517981417 BT10-10BT380-5 Antegrade Femur Piriformis Straight, 10.0mm x 380mm, 5/10cm ST; 887517981400 BT10
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.