FDAClass IIJune 14, 2017

Sesamoid Plasty recall

Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation…

Why was Sesamoid Plasty recalled?

Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number and : 521.025/521.028; Lot Number/Serial Numbers: SP-001, SP-002, SP-003, SP-004, SP-005, SP-006, SP-007, SP-008, SP-009, SP-010

Product
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation…
Recalling firm
Orthosoft, Inc. dba Zimmer CAS
Quantity
10
Distribution
Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
Recall date
June 14, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls