Vanguard Total Knee System Vanguard Open Box Femoral Components Item… — Class II medical device recall Z-1115-2017
Terminated recall by Zimmer Biomet, Inc., reported 2017-02-08, distributed nationwide. packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorre
| Recall number | Z-1115-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2017-01-04 |
| Classified | 2017-01-28 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2018-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CL, CN, CR, EC, GR, IN, IT, JP, KR, MX, MY, NL, PA, PL, SG, TH |
| Quantity | 15,000 |
| Reason classes | labeling |
| Lot numbers | J3719231, J3747463, J3747489, J3749445, J3749449, J3750117, J3750140, J3750403, J3750405, J3750406, J3750469, J3750471, J3750489, J3751054, J3751062, J3751073, J3753241, J3753243, J3753257, J3753262, J3753265, J3753268, J3753276, J3753278, J3753286, J3753287, J3753290, J3753293, J3753294, J3753304, J3753334, J3753337, J3753942, J3753967, J3753980, J3753986, J3753988, J3753991, J3753992, J3754010 and 460 more |
| Model numbers | 183100, 183102, 183104, 183106, 183108, 183110, 183112, 183113, 183120, 183122, 183124, 183126, 183128, 183130, 183132, 183133 |
Product
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
Reason for recall
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
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-1115-2017. 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.