Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues
Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with reports of the instrument being inadvertently removed from patients with the implant still engaged, which constitutes a significant injury risk.
Plain-English summary
Zimmer, Inc. is recalling 170 units of the Ardis Interbody System Inserter, a medical device intended for the delivery of the Ardis Implant into the cleared disc space. The recall is due to complaints regarding difficulty in turning the implant release knob after the final positioning of the implant.
The source text notes two reports where the inserter instrument was inadvertently removed from the patient while the implant was still engaged. The correction for this issue includes revised directions explaining the technique to remove the implant. The affected units are identified by part number 96-701-10001 and specific lot numbers, and were distributed in the USA and Europe.
The recalled product
- Product
- The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 170
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 (5)
- Part number: 96-701-10001
- Lot numbers: 61946711
- 61946712
- 61991588
- 62000412
Distribution
Distributed nationwide across the United States.
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