Z-2600-2017Class II

4.5 Broad Scp Plt 26-H Ster

Name: Z-2600-2017 4.5 Broad Scp Plt 26-H Ster
Creator: Zimmer Biomet, Inc.
Published: 2017-04-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-04-28 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of 4.5 BROAD SCP PLT 26-H STER on 2017-04-28. FDA classified it as Class II and gives the reason as "Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2600-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-28
Posted: 2017-06-15
Terminated: 2019-05-15
Recalling firm: Zimmer GmbH
Product: 4.5 Broad Scp Plt 26-H Ster
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Reason for recall: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Zimmer Biomet initiated a voluntary recall for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures. Compromised packaging may result in surgical delays, possible infections, and revision surgeries due to infections. The firm distributed letters to customer via FED EX on 04/28/2017. Customers were instructed to do the following: 1. Review this notification and ensure affected personnel are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form a. Return a digital copy to [email protected] within three (3) days. 4. Note that any hospitals and/or surgeons that received direct shipments of this product from Zimmer Biomet will be sent a copy of the Risk Manager and Surgeon Recall Notice directly. Additionally, Zimmer Biomet will also notify surgeons that have implanted the affected product within the past 12 months. It is important that you review the list of hospitals and/or surgeons included with the email notification sent to your facility to identify additional accounts Zimmer Biomet has not notified. Using the Additional Accounts Form provided with the email notice sent to your facility, return contact information for any additional hospitals and/or surgeons that may have received or used the affected product within the past 12 months. If there are no additional users to notify, please confirm this by annotating and returning the form provided indicating that no additional users have been identified. 5. Return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1 Inventory Return Certification Form to Zimmer Biomet within 2 weeks. a. For each return, send a copy of Attachment 1 to [email protected]. b. Include a
Quantity in commerce: 87
Distribution: Domestic: Puerto Rico, AK AL AR AZ CA CO CT FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY Foreign: CANADA, ALGERIA ARGENTINA AUSTRALIA BELGIUM BRAZIL BRIDGEND WALES CHINA DUBAI UAE EGYPT EL SALVADOR ENGLAND ESCHBACH GERMANY EXPORT DORAL FL FRANCE GERMANY GUATEMALA HONDURAS INDIA ITALY JAMAICA JAPAN JORDAN KOREA LEBANON DELIVERY SERVICE (LYNBROOK NY) MALAYSIA MEXICO MIAMI FL MOROCCO NETHERLANDS NEW ZEALAND NICARAGUA PANAMA PERU PHARR TEXAS POLAND PUERTO RICO RIO DE JANEIRO SAUDI ARABIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND THE NETHERLANDS TRIPOLI UK VIRGIN ISLANDS VA/DOD: Both see addresses below
Product codes and lots: 510K: K101073,P,K113224 Item Numbers: 47494502601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2600-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2593-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2594-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2595-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2596-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2597-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2598-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2599-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15
Z-2600-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-15

Product code KTT

K830196Class IICorstren Compression Tube & PlateZimmer, Inc. / cleared 1983-03-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)