The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2087-2014·Announced 2014-07-30

Synthes Orthopedic Guide Blocks Recalled for Incorrect Labeling

Synthes, Inc. is recalling 180 Guide Blocks for the Volar Distal Radius Plate System due to incorrect package labeling. The physical parts are correctly marked, but the packaging may identify the wrong side.

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: This is classified as a Moderate severity recall (Score 2) because it involves a minor labeling error on the packaging of a medical device. The source text explicitly states that the laser etching on the parts is correct, indicating the physical device is not defective, which aligns with the rubric for minor labeling errors or low-risk issues.

Plain-English summary

Synthes, Inc. is recalling 180 units of Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). These are orthopedic surgical instruments used in medical procedures. The recall was initiated because the products were found to be labeled incorrectly on the outside packaging.

Specifically, part number 03.111.600 (Right) was found in packages labeled as part number 03.111.601 (Left). The affected units are from lot number 10-5147. The FDA notes that the laser etching on the physical parts themselves correctly denotes the orientation, meaning the internal marking is accurate despite the packaging error.

The affected products were distributed nationwide in the United States and in Bermuda. Healthcare providers and facilities that have these specific part numbers and lot numbers should stop using them and contact Synthes, Inc. for instructions on return or replacement. Patients who have already had surgery using these instruments should contact their healthcare provider if they have concerns.

The recalled product

Product
Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument.
Manufacturer
Synthes, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
180

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 (3)

  • part no. 03.111.600
  • lot no. 10-5147
  • and part no. 03.111.601

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Synthes, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls