Z-2187-2012Class II

The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable...

Name: Z-2187-2012 The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable...
Creator: Zimmer, Inc.
Published: 2012-07-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-07-13 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and... on 2012-07-13. FDA classified it as Class II and gives the reason as "Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws". 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-2187-2012
Classification: Class II
Status: Terminated
Initiated: 2012-07-13
Posted: 2012-08-10
Terminated: 2013-09-24
Recalling firm: Zimmer GmbH
Product: The NCB Polyaxial Locking Plate System NCB screws 26mm: 02.03155.026, non-sterile Product is implantable screws indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These screws are intended for bicortical anchorage.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 13, 2012, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate the implicated lot in their inventory and user accounts; return all packaged units of this lot; and provide Zimmer with the name, complete mailing address, and phone number of each user facility and surgeon that have used the product via E-mail to [email protected]. Zimmer will send a follow-up Urgent Recall notification to these sub-accounts with instructions to verify the screw length of any screws already in the implant rack inventory prior to use in surgery. All implicated product is to be returned. The customers were also instructed to complete and return the Inventory Return Certification form to Zimmer via fax at +1-574-372-4265. If you have any questions about this correction and/or product removal, contact Zimmer at +1-877-946-2761.
Quantity in commerce: 24 to US Distributor with 7 further distributed
Distribution: Nationwide distribution: USA including states of: AZ, IL, IN, ME and NJ.
Product codes and lots: Part number 02.03155.026, lot 2649941

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2187-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2187-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-10

Product code HRS

K042695Class IINcb Plating SystemZimmer GmbH / cleared 2004-10-29

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)