Zimmer Recalls Trabecular Metal Reverse Shoulder Glenosphere Distractor
Zimmer, Inc. is recalling 771 units of the Trabecular Metal Reverse Shoulder Glenosphere Distractor due to potential mechanical failure if used without proper lubrication.
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 is classified as FDA Class II. The source text describes a mechanical defect (fracture/failure) in a surgical implant, which aligns with the rubric criterion for 'significant injury/property-damage reports' or structural defects in high-risk medical devices, warranting a Severe rating.
Plain-English summary
Zimmer, Inc. is initiating a lot-specific recall of the Trabecular Metal Reverse Shoulder Glenosphere Distractor (Item # 00-4309-049-00). The recall involves 771 units distributed worldwide, including the United States, Singapore, Brazil, Taiwan, Australia, Canada, Germany, and various other countries.
The recall is due to the potential for the device not to function properly if utilized without proper lubrication. This defect may result in the device failing to provide the necessary impact to the Glenosphere when the trigger is pulled. Additionally, there is a potential for the foot of the device to fracture.
The affected units are identified by specific lot numbers, including 60452884, 60461858, and 60531990, among others. The device is a prescription medical item that is non-sterile and requires sterilization before use. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx, Non sterile (sterilize before use) The Glenosphere Distractor must be able to attach, connect, or mate with the Glenosphere and remove it without dislodging or loosening the base plate from the…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 771
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 # 00-4309-049-00 and Lot Numbers: 60452884
- 60461858
- 60531990
- 60549559
- 60605842
- 60612781
- 60684768
- 60754281
- 60815778
- 60909547
- 60959086
- 60978338
- 61029048
- 61135953
- 61213252
- 61274877
- 61334929
- 61431672
- 61566464
- 61594740
Distribution
Distributed nationwide across the United States.
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