Z-0861-2012

5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative...

Name: Z-0861-2012 5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative...
Creator: Zimmer Inc.
Published: 2011-11-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-11-15 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of 5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative decisions with a variety of options for femoral and... on 2011-11-15. The reason FDA records is "Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0861-2012
Status: Terminated
Initiated: 2011-11-15
Posted: 2012-01-25
Terminated: 2013-09-24
Recalling firm: Zimmer GmbH
Product: 5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections and fixation of the implants.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Urgent Device Correction Letters, dated October 28, 2011, which included revised Surgical Technique to be used in the Zimmer Most Option Wedge Stem Distractor were sent November 15, 2011 to all Distributors requiring Correction letters be sent to all Hospital Risk Managers and Surgeons receiving devices. Directions were provided to destroy all previous versions of the surgical technique, and review the attached revised surgical technique, with warnings of proper direction of force needed for safe separation of mated components. A FAX -Back Certificate of Acknowledgement is to be sent to (574) 372-4265. Call Zimmer at 1-877-946-2761 with questions or concerns.
Quantity in commerce: 70
Distribution: Worldwide Distribution -- US, including states of TX, IN, GA, WI, MN, NJ, MO, IL, VA, MI, PA, NC, OR, FL, KS, NY, AZ, CO, and UT and country of Switzerland.
Product codes and lots: Lots 1519123, 1616672, 1627174, 60281712, 60773654, 60795066, 60841064, 61061148, 61348637, and 61770544.

Product code JDI

K002324Class IIModified to Modular Fr Severe Bone Loss TraumaSulzermedica / cleared 2000-08-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)