Zimmer Recalls ATS 3000 Tourniquets Due to Counterfeit Chip Failures
Zimmer is voluntarily removing 204 ATS 3000 Automatic Tourniquet Systems worldwide after complaints of failures caused by counterfeit chips.
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 failure during surgical procedures, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is conducting a voluntary removal of 204 units of the ATS 3000 Automatic Tourniquet System with hoses and LOP sensor. The device is intended for use by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures.
The recall was initiated after Zimmer received complaints regarding out-of-box failures and failures during surgical procedures. During these failures, the unit alarms, locks into a non-operational mode, and the display screen goes blank. Zimmer's investigation indicates the problem appears to be due to a counterfeit chip on the unit.
The affected units were distributed worldwide, including nationwide in the USA and internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE. Specific serial numbers and catalog codes are listed in the agency's recall record.
The recalled product
- Product
- ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 204
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 (20)
- Catalog 60-3000-101-00
- Serial # 3005IACJ
- 3006JAEP
- 3007CADR
- 3007EACT
- 3007EAKT
- 3007GAGR
- 3007HABK
- 3007KAAR
- 3007KAET
- 3008CADE
- 3008HAHC
- 3008LACK
- 3009AACN
- 3009HABA
- 3009LAEF
- 3010CABH
- 3010DAHG
- 3010GAAC
- 3010GAAJ
Distribution
Distributed nationwide across the United States.
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