Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder… — Class II medical device recall Z-2216-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-06-07, distributed in AR, AZ, CA, ID, IL, MD, MN, NY…. Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for t
| Recall number | Z-2216-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-04-26 |
| Classified | 2017-06-01 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2018-03-30 |
| Distributed | AR, AZ, CA, ID, IL, MD, MN, NY, OH, PA |
| Countries outside the US | CA |
| Quantity | 16 |
| UPC / GTIN / UDI-DI | 00880304462618 |
| Lot numbers | 270260 |
| Model numbers | 113956 |
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 product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty
Reason for recall
Zimmer Biomet is conducting a voluntary recall for a single lot of the Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System 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 from the lot had scratches and the other non-confirming threads.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2216-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.