Z-0312-2018Class II

PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular...

Name: Z-0312-2018 PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular...
Creator: Zimmer Biomet, Inc.
Published: 2017-06-29
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-06-29 / Terminated / root cause: manufacturing process

FDA source

Zimmer Biomet, Inc. began a recall of PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural... on 2017-06-29. FDA classified it as Class II and gives the reason as "Device was distributed with the etching missing from the product". 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-0312-2018
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Posted: 2018-01-04
Terminated: 2018-03-07
Recalling firm: Zimmer GmbH
Product: PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc+ Acetabular System is intended for uncemented use only.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Device was distributed with the etching missing from the product.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Zimmer Biomet, sent an, "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated 6/28/2017 via email and FedEx on approximately 06/29/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were Instructed to ensure appropriate personnel are notified, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to:[email protected] or fax to: 574-372-4265, return all affected products, and provide the names of any locations where product was further distributed to. If after reviewing this notice you have further questions or concerns please call the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of the call center operating hours will receive a prompt to record a voicemail or be transferred to an on-call representative in the case of an emergency. Alternatively, your questions may be sent by email to [email protected].
Quantity in commerce: 15 units
Distribution: Distributed domestically to MI, MN, ND.
Product codes and lots: Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0312-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0312-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-10	2018-01-04

Product code LPH

K093235Class IIIRingloc + Hybrid Acetabular SystemBiomet, Inc. / cleared 2010-04-30

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)