The Recall Desk
ModerateFDA (Devices)·Z-2216-2017·Announced 2017-06-07

Zimmer Biomet Recalls Modular Hybrid Glenoid Base for Quality Issues

Zimmer Biomet is voluntarily recalling 16 units of the Modular Hybrid Glenoid Base Large after two pieces with quality defects were shipped.

What this means for you

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 a voluntary precautionary recall for a Class II medical device where the hazard is limited to specific quality defects (scratches and non-conforming threads) on a small number of units, with no reported injuries or illnesses.

Plain-English summary

Zimmer Biomet, Inc. is conducting a voluntary recall of 16 units of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System. The recall involves a single lot (Lot Number: 270260) of the product, which is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty.

The recall was initiated after it was determined that two pieces from the lot were moved to finished goods and shipped despite having an open Non-Conformance Report (NCR). The NCR indicated that one piece had scratches and the other had non-conforming threads.

The affected units were distributed worldwide, including in the United States (OH, AZ, ID, PA, AR, MN, IL, CA, MD, NY) and Canada. Consumers and healthcare providers should check their inventory for the specific model number 113956 and lot number 270260. If the product is found, it should be removed from use and the recalling firm contacted for instructions.

The recalled product

Product
Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched pr
Affected units
16

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 (5)

  • Model Number: 113956
  • Modular Hybrid Glenoid Base Large
  • Item Number: 113956
  • Lot Number: 270260
  • UDI Number: (01) 00880304462618 (17) 211204 (10) 270260

Distribution

Distributed in 10 states: