Z-1169-2020Class II

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

Name: Z-1169-2020 SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block
Creator: DePuy Orthopaedics, Inc.
Published: 2020-01-03
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2020-01-03 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block on 2020-01-03. FDA classified it as Class II and gives the reason as "The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1169-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-02-13
Terminated: 2021-08-12
Recalling firm: Depuy Orthopaedics Inc.
Product: SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling firm notified customers with emailed Urgent Recall Notices on January 3, 2020. The letter instructed customers to do the following: 1. Cease further distribution or use of the affected products and quarantine. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return and of any affected devices. Director Materials Management / Operating Room Supervisor / Risk Managers / Field Action Coordinators and Surgeons 3. Review, complete, sign and return the business reply form (BRF) to DePuy Synthes ([email protected]) within 5 business days of receipt of this notification. 4. Forward this notice to anyone in your facility that needs to be informed, including surgeons who may have used this product. 5. If any impacted products have been forwarded to another facility, contact that facility and provide them with this letter. For clinical questions from surgeons, please contact DePuy Synthes Scientific and Medical Affairs mailbox [email protected]. ***Updated 7/9/2020*** Firm sent out new notifications dated July 13, 2020 communicating that event has expanded to include two additional lots.
Quantity in commerce: 140 total units
Distribution: Domestic distribution to IA, MA, NY, OH, and PA. Foreign distribution to Canada, China, Hungary, United Kingdom, and Singapore. ***Updated 7/9/20*** Expanded notice includes 6 new countries: Belgium, France, Germany, Maldives, New Zealand, and UAE
Product codes and lots: Lot SO2040929 ***Updated 7/9/20*** Lot SO2040602 Lot SO2037408 (None of this lot distributed in the US / OUS distribution only)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1169-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1169-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-12

Product code HTZ

K043223Class IIDepuy Cas Knee InstrumentationDePuy Orthopaedics, Inc. / cleared 2005-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)