Zimmer Persona Tibial Inserter Recalled for Potential Tip Fracture
Zimmer, Inc. is recalling 1,091 Persona Tibial Articular Surface Inserters due to a potential fracture of the instrument tip, which could cause tissue damage or require revision surgery.
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 risk of harm (tissue damage, revision surgery) where specific injury reports are not explicitly detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Zimmer, Inc. is recalling 1,091 units of the Zimmer PERSONA Tibial Articular Surface Inserter (Item # 42-5299-001-00). This manual surgical instrument is used for knee arthroplasty (orthopedic) procedures. The recall is due to a potential for fracture of the tip of the product.
The fractured tip is approximately 4mm x 7mm x 3.5mm in size. If the tip fractures and remains in the patient, it may result in pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip. Revision surgery may be required to remove the fractured tip.
The affected units were distributed worldwide, including the US nationwide (including Puerto Rico), South Korea, Singapore, Dominican Republic, Canada, Japan, and Germany. Specific affected lot numbers are listed in the agency documentation. Healthcare providers should stop using the affected instruments and contact Zimmer, Inc. for further instructions.
The recalled product
- Product
- Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Manual surgical instrument for knee arthroplasty (orthopedic).
- Manufacturer
- Zimmer, Inc.
- Affected units
- 1,091
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)
- Item No. 42-5299-001-00 Affected Lots: 56572679
- 56573170
- 56574318
- 56575056
- 56572918
- 56573378
- 56574538
- 56575057
- 56572975
- 56573379
- 56574540
- 56575058
- 56572978
- 56574123
- 56574618
- 56575059
- 56572981
- 56574124
- 56574619
- 56575060
Distribution
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