Zimmer Trabecular Metal Shoulder Humeral Stem Recalled for Bond Strength Defect
Zimmer, Inc. is recalling 10 units of Trabecular Metal Shoulder Humeral Stems because testing found bond strength below the minimum required specification in one zone.
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 is classified as FDA Class II. The hazard involves a structural defect (bond strength below specification) in a medical device, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Zimmer, Inc. is recalling 10 units of the Zimmer Trabecular Metal Shoulder Humeral Stem (Catalog No. 00434811113, Lot 62267250). The device is a sterile shoulder prosthetic replacement indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint, as well as humeral fractures.
The recall was initiated because testing revealed that the bond strength between the Trabecular Metal material and the substrate in one of three zones was approximately 80% of the minimum required by specification. The other two zones exceeded the minimum specification. This single manufacturing lot has the potential for the bond strength to be below the minimum required specification.
The affected units were distributed in the state of Illinois. No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate action, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- 00434811113, REF I4348-111-13 Zimmer Trabecular Metal Shoulder Humeral Stem 48 Degrees 11 mm Stem Diameter 130 mm Stem Length Trabecular Metal Humeral Stem 48 Degree 11mm x 130mm, Sterile, QTY 1, Rx Product Usage: Zimmer Trabecular Metal TM Humeral Stem is a shoulder…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 10
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 62267250
Distribution
Distributed in 1 state:
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