Z-1658-2008

Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder...

Name: Z-1658-2008 Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder...
Creator: Biomet, Inc.
Published: 2008-03-13
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-03-13 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid... on 2008-03-13. The reason FDA records is "The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1658-2008
Status: Terminated
Initiated: 2008-03-13
Posted: 2008-09-16
Terminated: 2008-10-15
Recalling firm: Zimmer GmbH
Product: Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgical instrument used to prepare the natural shoulder glenoid surface for implanting a Hybrid Glenoid component. This instrument is intended to function by drilling a hole into the natural glenoid surface allowing the center boss of glenoid implant to sit within the hole, and the non-articulating surface of the glenoid implant to rest flush onto the natural glenoid surface.
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by Urgent Medical Device Removal Notice dated 3/13/08 to discontinue use of the instruments and return to the firm. Operating room managers were sent a separate letter dated 3/13/08 and informed of the possible effects to patients from previous use of this instrument and it was suggested they monitor patients for these effects. If you have any questions contact Mary Hardesty at 1-800-348-9500 or (574) 372-3983.
Quantity in commerce: 189
Distribution: Class II Recall - Nationwide Distribution.
Product codes and lots: Lots 44550, 110100, 171760, 211530, 211550, 767940, 820310, 820330, 827250, 853810, 866590, 919780, 919790, 919800, 968270, 980230 and 980250.

Product code KWT

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)