FDAJune 5, 2020device
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
What to do
FDA enforcement status: Terminated
Brands named
orthopediatrics
UPCs
00841132122211
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAFRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System2024-07-04
- FDAOrthex Large Bone Shoulder Bolt, model no. AS-172022-09-12
- FDAOrthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN2022-06-29
- FDAOrthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Numbe...2020-07-06
- FDAOrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.2020-06-05
- FDAOrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-00322019-08-19
- FDAModel No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the sy...2019-08-19
- FDAModel No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within t...2019-08-19
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