Zimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues
Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.
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. The source text indicates that seal integrity testing met acceptance criteria and no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer, Inc. is recalling specific Free-Lock orthopedic devices, including lag screws, supracond tubes, and tube & SCP plates. The affected items are identified by codes starting with 0011810 and 0011811. A total of 7,044,680 units are involved in this recall.
The recall was initiated after Zimmer reviewed historic packaging validations at its Zimmer Manufacturing B.V. facility in Ponce, Puerto Rico. The company determined that packaging operations in Building 1 were not properly validated. Although subsequent seal integrity testing showed that the packaging met acceptance criteria for sterile barrier integrity, Zimmer decided to recall all non-expired lots sterile packaged in that specific facility.
These products were distributed nationwide in the United States and in numerous countries worldwide, including Belgium, Canada, China, Germany, India, Japan, and the United Kingdom. Healthcare providers and patients should check their inventory or medical records for these specific product codes and contact Zimmer for further instructions.
The recalled product
- Product
- FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 7,044,680
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 44 recalled by Zimmer, 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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