New Standard Device recalls
4 official recalls and safety alerts involving New Standard Device since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with New Standard Device or the relevant agency.
- 2023-06-21
USNew Standard Device Inc recalls 'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
The threads on posts stripping out when tensioned during application process.
FDA · DeviceNew Standard Device IncU.S. Nationwide distribution in the states of AZ, CT, OH, TX, VA.Official notice →- 2022-09-07
- US
New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin…
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
FDA · DeviceNew Standard Device IncU.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: NoneOfficial notice → - 2022-06-29
- US
New Standard Device Inc recalls Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A
Due to manufacturing processing error, wrench causing stripping when torqueing nuts.
- 2022-06-15
- US
New Standard Device Inc recalls 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating System
1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The increased wire diameter and new manufacturing process are meant to provide a stronger wire and reduced breakage.
FDA · DeviceNew Standard Device IncUS Nationwide distribution in the states of AZ, VA, OH, CT, TX, NC, GA.Official notice →