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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 1
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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