FDA-Device2026-07-01Class IIPROCESSING DEFECT
Zimmer Off-Axis Comprehensive Shoulder System Reamer Guide recalled for plastic breakage during surgery
What this means
Zimmer has recalled a plastic reamer guide used in shoulder surgery because the plastic can catch and break during the reaming procedure. Five complaints have been received describing this issue. No injuries have been reported.
- Contact Zimmer if you have this device in stock or in use.
- Review the lot numbers 099457 and 099458 to identify affected units.
- Do not use affected guides until you receive further instructions from Zimmer.
The agency's original wording
Hazard
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
474 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2527-2026Want us to check the next one for you?
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