SIGMA HP MBT Non-Keel Punch Knee Instrument — Class II medical device recall Z-0787-2016
Terminated recall by DePuy Orthopaedics, Inc., reported 2016-02-17, distributed nationwide. Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause t
| Recall number | Z-0787-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2016-01-08 |
| Classified | 2016-02-09 |
| Reported by FDA | 2016-02-17 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CH, CN, CZ, DE, DK, EG, ES, FR, GB, GR, HU, IE, IL, IN, IT, JP, KR, LU, MY, NL, NO, NZ, PL, PT, RU, SE, SG, SI, TH, TR, ZA |
| Quantity | 351 |
| UPC / GTIN / UDI-DI | 10603295227366, 10603295227373, 10603295227380, 10603295227403, 10603295227410 |
Product
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
Reason for recall
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision 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-0787-2016. 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.