VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
Reported: September 4, 2013 Initiated: June 19, 2013 #Z-2094-2013
Product Description
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
Reason for Recall
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 85, 794 units in total
- Distribution
- Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jordan, Iraq, Canary Islands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.. Recalled by Zimmer, Inc.. Units affected: 85, 794 units in total.
Why was this product recalled? ▼
Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 4, 2013. Severity: Moderate. Recall number: Z-2094-2013.
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