The Recall Desk
HighFDA (Devices)·Z-2242-2016·Announced 2016-07-27

Encore Medical Recalls Modified Linear Standard and Lateral Neck Trials

Encore Medical is recalling 14 neck trial sets because a retaining ring component can disassemble from the body of the neck.

What this means for you

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 involves a structural failure of a medical device component (retaining ring disassembly) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Encore Medical, Lp is recalling 14 units (7 sets) of Modified Linear Standard/Lateral Neck Trials with Spring Sides, reference numbers S-200635 and S-200636. The recall was initiated due to a reported failure where the retaining ring component of a neck trial became disassembled from the body of the neck.

The affected products were distributed to facilities in Colorado, Idaho, and Texas. The specific lot numbers involved are 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, and 314R1901.

Healthcare providers and facilities should stop using the affected neck trials and contact Encore Medical for instructions on return or replacement.

The recalled product

Product
MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
Manufacturer
Encore Medical, Lp

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 (6)

  • Lot: 313R1000
  • 313R1900
  • 313R1901
  • 314R1000
  • 314R1900
  • 314R1901

Distribution

Distributed in 3 states: