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PT113950 PT HYBRID Glenoid Post recallZ-0660-2013 · Biomet, Inc. · initiated Dec 6, 0012

Class II Terminated All recalls posted in January 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-0660-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 6, 0012
Posted by the FDA
Jan 9, 2013
Recalling firm
Biomet, Inc.
Quantity
1050
Product code
KWS
FDA submissions
K060694
Distribution
Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile.

Product description

PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

5 devices cleared under K060694 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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