Data Foundry

Medical device recalls 2020

SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK — Class II medical device recall Z-1169-2020

Terminated recall by DePuy Orthopaedics, Inc., reported 2020-02-19, distributed in IA, MA, NY, OH, PA. The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.

Recall numberZ-1169-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDePuy Orthopaedics, Inc., Warsaw, IN, United States
Recall initiated2020-01-03
Classified2020-02-12
Reported by FDA2020-02-19
Terminated2021-08-12
DistributedIA, MA, NY, OH, PA
Countries outside the USAE, BE, CA, CN, DE, FR, GB, HU, NZ, SG
Quantity140 units
Lot numbersO2037408, O2040602, O2040929
Model numbers966115

Product

SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.

Reason for recall

The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable 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-1169-2020. 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.