The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1125-2014·Announced 2014-03-12

Synthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert

Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.

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 2/5 (Moderate).

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 and involves a minor labeling error (incorrect package insert) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws (part no. 02.231.240, lot no. 823111). The recall is due to a labeling correction where one package contained a GP0006 (Anterior Cervical Vertebrae Plate System) insert instead of the correct GP2848 (4.5mm VA-LCP Curved Condylar Plate System) insert.

The affected devices were distributed nationwide, including in Georgia, California, Texas, Missouri, Ohio, Pennsylvania, Washington, Alabama, Indiana, Arizona, Michigan, Iowa, Tennessee, Kentucky, North Carolina, Virginia, New York, Louisiana, Illinois, Utah, and Kansas. This recall is classified as Class II by the FDA.

Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed above. If the affected device is found, it should be removed from use and returned to Synthes, Inc. according to the company's instructions.

The recalled product

Product
Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable…
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
45

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 (2)

  • part no. 02.231.240
  • lot no. 823111

Distribution

Distributed nationwide across the United States.

The notice also names 21 states specifically:

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