The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1801-2014·Announced 2014-06-25

Biomet Recalls EZPass Suture Retriever Due to Nitinol Wire Buckling

Biomet is recalling 100 units of EZPass Suture Retriever instruments because the nitinol wire may buckle and become kinked, making the device difficult to use.

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, but the source text does not report any injuries, illnesses, or hospitalizations. The hazard is a functional defect (buckling/kinking) that makes the device difficult to use, which aligns with the 'Moderate' severity criteria for low-risk issues without reported harm.

Plain-English summary

Biomet, Inc. is recalling 100 units of the EZPass Suture Retriever, Nitinol, Single Pack (Part number 10007380). This is a sterile, single-use arthroscopic instrument used in orthopedic surgery to aid in passing suture through soft tissue. The affected units are distributed nationwide and include Part numbers 110007380 with Lot 223570 and 803860.

The recall was initiated because the nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked. This defect makes the wire or monofilament difficult to use during surgical procedures.

The U.S. Food and Drug Administration has classified this as a Class II recall. No specific instructions for consumers are provided in the source text, but healthcare facilities should stop using the affected units and contact the manufacturer for further guidance.

The recalled product

Product
EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
100

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)

  • Part numbers 110007380 Lot 223570 and 803860

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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