Zimmer Biomet Recalls HA Pins and Hoffman/Colles Pins Due to Cleaning Issues
Zimmer Biomet is recalling HA Pins and Hoffman/Colles Pins because elevated bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
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 Class II medical device with a contamination hazard (bacterial endotoxin and debris) that poses a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Zimmer Biomet, Inc. is recalling specific lots of HA Pins (DFS HA Cort Screw) and Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit). These medical devices are intended for osteosynthesis, external fixation of fractures, or bone lengthening procedures.
The recall was initiated because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The affected products were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, and others.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for further instructions on the recall process.
The recalled product
- Product
- HA Pins (DFS HA Cort Screw), Hoffman/Colles Pins (Colles CSER Sterile w/ Pin Kit) Item Nos: HAA60-09030 HAA60-09040 HAA60-10030 HAA60-10040 HAA60-11030 HAA60-11040 HAA60-11050 HAA60-12040 HAA60-12060 HAA60-13030 HAA60-13040 HAA60-13050 HAA60-13060 HAA60-13070…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 178,886
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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