The Recall Desk
ModerateFDA (Devices)·Z-2381-2012·Announced 2012-09-26

Integra Recalls 2.7mm Drilling Guides Due to Breakage During Use

Integra Life Sciences is recalling 2,389 units of 2.7mm Drilling Guides because they may break during surgical use, potentially increasing procedure time.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source explicitly states that no patient injuries resulted from the breakage, and the identified risk is limited to increased surgical time, fitting the criteria for a moderate severity recall involving low-risk issues without reported harm.

Plain-English summary

Integra Life Sciences is recalling 2,389 units of 2.7mm Drilling Guides, Catalogue No. 219635ND. These reusable instruments are used in conjunction with a drill to prepare oriented holes in bone for the insertion of locking screws in various compression plate systems, including Tiblaxis, Uni-CP, Advansys MLP, and Advansys DLP.

The recall was initiated after Integra's quality system identified an adverse trend in complaints regarding the breakage of the drilling guides during use. While none of the reported complaints resulted in patient injuries, the breakage in some cases led to an increase in the time required to complete the surgical procedure. A physician consulted to assess patient risk concluded that any potential risk would be transient, self-limiting, or minor.

The affected units were distributed worldwide, including nationwide in the United States and in several countries in Europe, the Middle East, and Africa. Specific lot numbers for the affected guides are listed in the official recall documentation. Users should stop using the affected devices and contact the manufacturer for instructions on replacement or return.

The recalled product

Product
The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems. The Drilling Guid
Manufacturer
Integra Life Sci.
Category
Medical Device — Surgical Instrument
Hazard

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 (20)

  • The Lot No's for the affected 2.7mm Drilling Guides are: E1DT
  • E4EX
  • E57T
  • E5YA
  • E64W
  • E6GN
  • E6RB
  • E6WP
  • E7UL
  • E86B
  • E8UC
  • E9PX
  • E9Q5
  • E9QD
  • EBNY
  • EEYJ
  • EF11
  • EFCM
  • EGT6
  • EH6X

Distribution

Distributed nationwide across the United States.

The notice also names 35 states specifically:

Related recalls

Same hazard · breakage

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