Zimmer Recalls Nonsterile Orthopedic Rasp Handles Due to Assembly Failure
Zimmer, Inc. is recalling 412 units of VER2 DBL OFFSET RASP HANDLE, LT Nonsterile because the handle may fail to remain assembled to the rasp during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical failure (fracture of leaf spring) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer, Inc. is recalling 412 units of the VER2 DBL OFFSET RASP HANDLE, LT Nonsterile. The recall involves Item Number 82016761201 and Lot Numbers 97009494, 97009561, and 97009569. The product was distributed nationwide in the United States and in Australia, France, Germany, Italy, Switzerland, and Canada.
The firm received complaints that the handle failed to remain assembled to the rasp during use. The source text attributes this to various failure modes, including the fracture of the leaf spring.
Consumers and healthcare providers should stop using the affected products and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
- Manufacturer
- Zimmer, Inc.
- Affected units
- 412
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Item Number 82016761201 Lot Number 97009494
- 97009561
- 97009569
Distribution
Part of a larger recall action
This product is one of 16 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 16 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · mechanical failure
See all →- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateZimmer Anatomical Shoulder Handle Recalled Due to Attachment and Removal Difficulties
FDA (Devices) · 2015-05-06
- HighZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Affixus Hip Fracture Nails Due to Assembly Defect
FDA (Devices) · 2018-02-07
- SevereZimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Affixus Hip Fracture Nail Due to Assembly Defect
FDA (Devices) · 2018-02-07
- HighZimmer Recalls Distal Lateral Femoral Locking Plates Due to Sterility Concerns
FDA (Devices) · 2014-01-08