Z-0885-2016Class II

HipLOC CHS Plate/Lag Screw Introducer

Name: Z-0885-2016 HipLOC CHS Plate/Lag Screw Introducer
Creator: Biomet, Inc.
Published: 2016-02-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2016-02-16 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of HipLOC CHS Plate/Lag Screw Introducer on 2016-02-16. FDA classified it as Class II and gives the reason as "A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked". 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-0885-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-16
Posted: 2016-02-25
Terminated: 2017-02-14
Recalling firm: Zimmer GmbH
Product: HipLOC CHS Plate/Lag Screw Introducer
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to [email protected] prior to return of product. You do not need to complete the Biomet UK response form. Use priority carrier for your shipment. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: "Online: www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or "Call (800)FDA-1088 Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 23 units
Distribution: US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.
Product codes and lots: Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0885-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-25

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)