Z-0713-2011

Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet...

Name: Z-0713-2011 Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet...
Creator: Biomet, Inc.
Published: 2010-09-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-09-13 / Terminated

FDA source

Biomet, Inc. began a recall of Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN Intended for total shoulder... on 2010-09-13. The reason FDA records is "The firm received complaints regarding fracturing of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0713-2011
Status: Terminated
Initiated: 2010-09-13
Posted: 2010-12-16
Terminated: 2011-07-27
Recalling firm: Zimmer GmbH
Product: Custom Comprehensive Shoulder Bio-Modular Base, 44 mm Humeral Tray standard, sterile, REF CP561510, Biomet Orthopedics, Warsaw, IN Intended for total shoulder replacement in a reverse configuration.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: The firm received complaints regarding fracturing of the device.
FDA root cause: Pending
Action: The firm sent "URGENT MEDICAL DEVICE RECALL NOTICE" dated 9/13/2010 to their distributors and customers. The letters stated the reason for the recall and what may happen as a result of the fracture of the device. The notices stated that the recalled devices should be immediately located, discontinued from use, and shipped back to Biomet. Customers should follow the instructions on the "FAX Back Response Form." If the affected product was further distributed, hospital personnel must be notified of the recall via the enclosed "Dear Biomet Customer" notice. The firm sent "URGENT MEDICAL DEVICE RECALL NOTICES' to implanting surgeons. These letters informed the surgeons of the recall and instructed them to continue to monitor the patient for fracture of the device. Customers are to confirm receipt of the notice by calling 800-348-9500 ext 3755 or 3983. Questions should be directed to 574-371-3755 or 574-372-3983.
Quantity in commerce: 45 both products
Distribution: Nationwide Distribution -- NY, VA, MD, AL, CO, SD, TX, and OK.
Product codes and lots: Lot numbers: 068700, 246790, 314260, 437920, 557030, 608210, 746530, 787230, 810390 and 883100.

Product code KWS

K080642Class IIComprehensive Reverse ShoulderBiomet, Inc. / cleared 2008-07-09

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)