Zimmer Biomet Recalls RingLoc Hip System Bone Screws Due to Packaging Error
Zimmer Biomet is recalling 809 units of RingLoc Hip System Self-Tapping Bone Screws because 30mm screws may have been packaged as 20mm screws, and vice versa.
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 (incorrect screw length during surgery) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Zimmer Biomet, Inc. is recalling 809 units of the Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium (Item Number: 103531). The recall involves two lengths of the 6.5mm screw, specifically the 20mm and 30mm variants, which are accessories to total hip implants.
The recall was initiated because there is a potential for the 30mm screws to be packaged as 20mm screws and vice versa. This packaging error could result in the wrong length of screw being used during a surgical procedure.
The affected products were distributed worldwide, including in the United States, Chile, China, Costa Rica, Gujarat (India), Japan, Mexico (CDMX), and Singapore. The specific lot numbers involved are 523430, 523450, 860840, 860850, and 860860. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected screws.
The recalled product
- Product
- Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 809
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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