Zimmer Biomet Recalls Reusable Orthopedic Instruments Due to Durability Concerns
Zimmer Biomet is recalling reusable instruments for knee, hip, trauma, and extremities because their durability characteristics were not established.
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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling reusable instruments used in the Knee, Hip, Trauma, and Extremities segments. The recall was initiated because the durability characteristics of these instruments were not established.
The recall covers all lots in distribution prior to May 8, 2017. The company distributed these instruments nationwide and worldwide, with more than 10,000,000 units distributed over the last 10 years.
Consumers and healthcare facilities should stop using the affected instruments and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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 (1)
- All lots in distribution prior to 5/8/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighCoaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
Similar recalls
- HighZimmer Biomet Flexible Shaft Instruments Recalled for Infection Risk
FDA (Devices) · 2018-03-14
- SevereZimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- SevereZimmer Biomet Recalls Orthopedic Surgical Drill Bits and Screw Taps
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Orthopedic Surgical Drill Bits Due to Fracture Risk
FDA (Devices) · 2017-10-04
- HighZimmer Biomet Recalls Persona Partial Knee System Impactor Pads
FDA (Devices) · 2018-02-21
- HighZimmer Biomet Recalls M/L Taper Hip Prostheses Due to Black Residue
FDA (Devices) · 2018-07-11