The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1548-2013·Announced 2013-06-26

Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset

Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the defect involves a structural failure of a surgical guide that could lead to improper placement during a procedure, meeting the criteria for a Severe rating.

Plain-English summary

Biomet, Inc. is recalling 17 units of the Superior Approach Resection Guide Assembly. This medical device is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. The affected units are identified by catalog number 010001814 and lot numbers 318520 and 644720.

The recall was initiated after an investigation identified that the slot on the resection guide is offset in the wrong direction. This defect may prevent the Steinman pin, which is intended to hold the guide into place, from coming into contact with the bone. The agency has classified this recall as Class II.

The affected products were distributed worldwide, including nationwide in the United States (specifically Utah, Texas, Alabama, Kentucky, and Wisconsin) and in Australia, The Netherlands, Korea, and Canada. Healthcare providers should stop using the affected devices and contact Biomet for further instructions.

The recalled product

Product
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
17

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)

  • Catalog number: 010001814 and lot numbers: 318520 and 644720.

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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