Zimmer Anatomical Shoulder Handle Recalled Due to Attachment and Removal Difficulties
Zimmer GmbH is recalling 30 units of Anatomical Shoulder Handles for Rasps due to high resistance during attachment and seizing during removal, which may delay 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 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, but the source text describes a mechanical defect leading to potential surgical delay rather than reported injuries, hospitalizations, or structural failures that would warrant a higher severity score.
Plain-English summary
Zimmer GmbH is recalling 30 units of the Anatomical Shoulder Handle for Rasp (Item: 01.04233.000). This medical device is used during total joint arthroplasty of the shoulder. The affected units are from Lot Numbers 13870129 and 13878179.
The recall was initiated due to complaints regarding difficulties in attaching the handle to the rasp, characterized by high resistance. Additionally, once attached, users reported difficulties in removing the handle due to the components seizing up. These mechanical issues have the potential to cause delays in surgery.
The recalled products were distributed to the states of Indiana, Georgia, Wisconsin, Missouri, Pennsylvania, Kansas, Tennessee, and New York. Healthcare providers and facilities that have received these items should stop using them and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
- Manufacturer
- Zimmer Gmbh
- Affected units
- 30
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)
- Lot Number(s): 13870129 & 13878179.
Distribution
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