Z-0660-2013Class II

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder...

Name: Z-0660-2013 PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder...
Creator: Biomet, Inc.
License: https://open.fda.gov/license/

Zimmer GmbH / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented. FDA classified it as Class II and gives the reason as "Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead...". 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-0660-2013
Classification: Class II
Status: Terminated
Posted: 2013-01-09
Terminated: 2013-11-08
Recalling firm: Zimmer GmbH
Product: PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events: 1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is implanted, then a gap of 1-3 mm will be prese
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet Inc. sent a Urgent Medical Device Recall Notices dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The notice identified the reason for the recall including directions to immediately locate, discontinue use of the device. Surgeons were asked to continue monitoring of patients implanted. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with product to be returned are asked to obtain RGA # by calling 574-372-6677 . A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 574-371-1570, Monday- Friday 8 a.m. to 5 p.m.
Quantity in commerce: 1050
Distribution: Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.
Product codes and lots: Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0660-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0660-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-09

Product code KWS

K060694Class IIModular Hybrid GlenoidBiomet Manufacturing Corp / cleared 2006-12-11

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)