The Recall Desk
HighFDA (Devices)·Z-0786-2022·Announced 2022-03-23

Wright Medical ORTHOLOC Surgical Screw Recalled for Incorrect Component Packaging

Wright Medical Technology's ORTHOLOC Non-Locking Screw was recalled due to a packaging error in lot #73967511638696, where locking screws were mistakenly packaged instead. The affected product was distributed to France.

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: This is an FDA Class II recall involving a manufacturing/packaging defect (incorrect screw component) in surgical hardware with no reported injuries or illnesses. Per the rubric, Class II recalls without hospitalization reports and with no reported injuries fall under 'risk-of-harm products where injury has not yet been reported,' which scores as High (3).

Plain-English summary

Wright Medical Technology is recalling ORTHOLOC Non-Locking Screws (2mm x 8mm, reference number 5201120008), which are components of the ORTHOLOC 2.0/2.4 Plate System. The recall affects lot #73967511638696.

The recalled product contains an incorrect screw—locking screws were packaged instead of non-locking screws.

The affected product was distributed internationally to France.

The recalled product

Product
Wright Medical Technology, Inc. ORTHOLOC Non-Locking Screw 2mm x 8mm, REF 5201120008, non-sterile, a component of the ORTHOLOC 2.0/2.4 Plate System.
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic / Surgical Fixation
Hazard
  • manufacturing-error
  • component-defect

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 (1)

  • Lot #73967511638696

Distribution

Distribution scope not specified by the agency.

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