The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2816-2020·Announced 2020-08-26

DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues

Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.

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: The recall involves a medical device with a potential structural defect (reduced locking strength) that 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 without reported injury.

Plain-English summary

Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm (Part Number 241.381). The recall is due to the possibility that one or more dimensional features, including thread pitch diameter depth, thread minor diameter depth, plate thickness, and end length, are out of tolerance.

These dimensional deviations can potentially result in a reduced locking strength of an LCP screw. The affected products are identified by Lot Number 29P6036 and UDI 10886982166913. The products were distributed nationwide in the United States.

The plates are intended for the fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone. Healthcare providers and facilities should identify and quarantine the affected units.

The recalled product

Product
DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone.…
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
191

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 Number: 29P6036 UDI: 10886982166913

Distribution

Distributed nationwide across the United States.

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