RESTORE 219328Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705005758), received between Jan 16, 2024 and Jan 16, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN MALAYSIA 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 5 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18520040 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN MALAYSIA 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.THIS IS REPORT 1 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519451 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN (B)(6) 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 6 OF 6 FOR THE SAME EVENT IN PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519220 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN MALAYSIA 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 4 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519141 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN MALAYSIA 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519111 ↗
• MalfunctionJan 16, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP IN MALAYSIA 6 ACL BAYPN W/EYE .094X18" *EA BAYONET PINS WERE FOUND BENT WHEN RECEIVED AND INSPECTED. IT WAS REPORTED THAT THERE WAS NO SIGNS OF DAMAGE TO THE EXTERNAL CONTAINER. IT WAS DETERMINED THAT THE PINS WERE BENT WHEN ROLLED ON A TABLE AND SHOWED SIGNS OF INTERRUPTED ROLLING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 6 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519059 ↗