Zimmer Free Lock Femoral Hip Fixation System Compression Lag Screw Recall
Zimmer is recalling Free Lock Femoral Hip Fixation System Compression Lag Screws because a packaging failure compromised sterility.
What this means for you
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, and the hazard involves compromised sterility of an orthopedic implant, which poses a risk of harm (infection) even though no specific injuries are reported in the source text.
Plain-English summary
Zimmer, Inc. is recalling the Free Lock Femoral Hip Fixation System Compression Lag Screw. The recall involves several lengths (55 to 150 mm) and diameters (12.7 and 15.8 mm), with item codes starting with 00-1181-05, 00-1181-10, and 00-1181-15. A total of 85,794 units are affected.
The recall was initiated because a single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed a leak test, which compromised the sterility of the product. The affected devices were distributed worldwide, including the United States (nationwide, including Puerto Rico and US Virgin Islands) and numerous international locations such as Canada, Australia, and various countries in Europe, Asia, and the Middle East.
Healthcare providers and patients should check their inventory and records for the specific item codes and lot numbers listed in the official recall notice. If the affected devices are in use, providers should contact Zimmer, Inc. for instructions on replacement or removal.
The recalled product
- Product
- Free Lock Femoral Hip Fixation System Compression Lag Screw . Several lengths (55 to 150 mm) and diameters (12.7 and 15. 8 mm). Item codes starting with 00-1181-05, 00-1181-10 and 00-1181-15. ZIMMER Compression Hip Screw, orthopedic implant.
- Manufacturer
- Zimmer, Inc.
Distribution
Part of a larger recall action
This product is one of 5 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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