The Recall Desk
ModerateFDA (Devices)·Z-3102-2017·Announced 2017-09-06

Encore Medical Recalls Turon Glenoid Reamers Due to Dimensional Error

Encore Medical is recalling five Turon Glenoid Reamers because the spherical radius cutting surface was manufactured with the wrong dimension, resulting in a larger surface than intended.

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a dimensional manufacturing error without reporting any specific injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Encore Medical, Lp is recalling five units of the Modified/Special Instrument, Turon Glenoid Reamers, Ream and Run. The affected catalog numbers are S-200956 (5mm PIN, SIZE 46), S-200957 (5mm PIN, SIZE 50), and S-200958 (5mm PIN, SIZE 58). The specific lot numbers are 535U1000, 536U1000, and 537U1000.

The recall was initiated because the models used to manufacture these specific instruments had the wrong dimension used to create the spherical radius cutting surface. As a result, the device design allows for a larger spherical radius cutting surface than originally intended.

The recalled devices were distributed to facilities in Ohio and Virginia. No specific consumer instructions are provided in the source text beyond the identification of the affected units.

The recalled product

Product
MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58
Manufacturer
Encore Medical, Lp
Affected units
5

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 (5)

  • Catalog number
  • Lot Number S-200956
  • 535U1000 S-200957
  • 536U1000 S-200958
  • 537U1000

Distribution

Distributed in 2 states:

Same hazard · dimensional error

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