Comprehensive Humeral Tray Taper Extraction Pliers — Class II medical device recall Z-1750-2020
Terminated recall by Biomet, Inc., reported 2020-04-29, distributed nationwide. There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
| Recall number | Z-1750-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2020-03-13 |
| Classified | 2020-04-20 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, IN, NL |
| Quantity | 125 |
| Reason classes | sterility |
| Lot numbers | 079630, 175100, 175110, 197900, 233080, 362370, 364910, 465800, 489000, 494350, 494350R, 516230, 742760 |
| Model numbers | 110028522 |
Product
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.
Reason for recall
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
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-1750-2020. 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.