Sterile Knee Instruments Disposable Fluted Headless Pins — Class II medical device recall Z-0373-2019
Terminated recall by Howmedica Osteonics Corp., reported 2018-11-14, distributed nationwide. Potential for outer pouch sterile barrier to be compromised
| Recall number | Z-0373-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2018-09-10 |
| Classified | 2018-11-02 |
| Reported by FDA | 2018-11-14 |
| Terminated | 2020-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 15 pouches |
| Reason classes | sterility |
| Lot numbers | C22130X |
| Model numbers | 7650-2038A |
| Expiration dates | 2023-08-05 |
Product
Sterile Knee Instruments Disposable Fluted Headless Pins, DIA 3.2mm LNTH 89mm, REF 7650-2038A - Product Usage: Howmedica Osteonics Corp. (Stryker, Joint Reconstructive Division) Sterile Instrumentation consists of manual surgical instrumentation intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries.
Reason for recall
Potential for outer pouch sterile barrier to be compromised
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-0373-2019. 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.