Exactech Novation Calcar Planer Guide Tip Recalled for Labeling Clarification
Exactech is recalling 477 Novation Calcar Planer Guide Tips to update labeling with a caution about instrument breakage.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to clarify surgical technique and add a caution statement regarding instrument breakage, which aligns with the rubric for moderate severity involving labeling errors or precautionary measures.
Plain-English summary
Exactech, Inc. is recalling 477 units of the 1.5" Novation Calcar Planer Guide Tip. These reusable surgical instruments are intended to assist surgeons in the implantation of Novation hip system components during total hip replacement procedures.
The recall was initiated because the firm determined that the labeling regarding surgical technique should be updated. The update is intended to clarify the proper technique and instrumentation for performing calcar planing to the bone. Specifically, the labeling will include a caution statement regarding the potential for instrument breakage if bending or torsional forces are applied.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in various international markets. The specific catalog number is 161-30-00, associated with multiple manufacturing lots. Users of these instruments should refer to the updated labeling for proper usage instructions to avoid instrument breakage.
The recalled product
- Product
- Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for…
- Manufacturer
- Exactech, Inc.
- Affected units
- 477
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 (18)
- Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001
- 38878-002
- 49777-001
- 51825-005
- 51825-006
- 52224-007
- 52224-005
- 52224-006
- 57167-001
- 59775-003
- 62580-004
- 66464-003
- 66464-004
- 70720-001
- 71530-001
- 73477-002
- 75153-001
- and 74999-001.
Distribution
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