The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2560-2014·Announced 2014-09-10

OrthoPediatrics ACL Sleeve Installation Tool Recalled for Weld Fractures

OrthoPediatrics Corp is recalling 56 ACL Sleeve Installation Tools due to weld fractures. The tools are used in pediatric and small stature adult ACL reconstruction systems.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect (weld fracture) in a medical device used during surgery, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

OrthoPediatrics Corp is recalling 56 units of the ACL Sleeve Installation Tool, available in sizes ranging from 6mm to 10.0mm. These tools are part of the OrthoPediatrics ACL Reconstruction System, which is designed for pediatric and small stature adult patients. The specific issue identified is weld fractures on the installation tool.

The recalled tools are used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone during ACL reconstruction procedures. The recall covers units distributed nationwide in the United States. Specific lot codes and part numbers are listed in the official recall documentation.

Healthcare providers and patients should stop using the affected tools immediately. OrthoPediatrics Corp is the recalling firm responsible for managing this safety action. No specific instructions for consumer action are provided in the source text beyond the identification of the defect.

The recalled product

Product
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one…
Manufacturer
OrthoPediatrics Corp
Category
Medical Device — Surgical Instrument
Hazard
Affected units
56

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • F132763 01-1008-0042 F132763
  • F132764 01-1008-0043 F132765
  • F132766 01-1008-0044 F132766

Distribution

Distributed nationwide across the United States.

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