The Recall Desk
HighFDA (Devices)·Z-1413-2017·Announced 2017-03-15

Encore Medical Recalls RSP Impaction Fixtures Due to Material Wear

Encore Medical is recalling 626 RSP Impaction Fixtures because polymer material wore off during assembly, potentially affecting the humeral stem coating.

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 is classified as FDA Class II, and the source describes a physical defect (material wear) in a medical device without reporting 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 626 units of the RSP Impaction Fixture. The recall is due to a manufacturing issue identified during the Turon assembly process.

During assembly, impaction forces caused the black acetal copolymer material from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating. This wear could compromise the integrity of the coating on the medical device.

The affected units were distributed in the United States, South Korea, Australia, Canada, the United Kingdom/Ireland, and Germany. Specific lot codes for the recalled units include 109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, and 81722L02. Healthcare providers and facilities should check their inventory for these specific codes and contact Encore Medical for further instructions.

The recalled product

Product
RSP Impaction Fixture
Manufacturer
Encore Medical, Lp
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
626

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 (15)

  • 109931L01
  • 109931L02
  • 115670L15
  • 115670L16
  • 128092L08
  • 128092L09
  • 137917L16
  • 167829L06
  • 52258L01
  • 52258L01A
  • 67428L01
  • 76386L01
  • 76386L02
  • 81722L01
  • 81722L02

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Encore Medical, Lp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Encore Medical, Lp

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Same hazard · material wear

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