PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2
FDA device recall Z-2948-2020 · posted 2020-09-09 · Open, Classified
Recall details
- Recalling firm
- MicroPort Orthopedics Inc.
- Reason for recall
- MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8).
- Action taken
- The firm, MicroPort Orthopedics Inc., disseminated a "URGENT ACTION REQUIRED" VOLUNTARY DEVICE PRODUCT RECALL notice dated 7/31/2020 by mail to its consignees. The letter directed the consignee to doe the following: Please check your stock, including all consignment stock to immediately determine if you have any affected product. PLEASE NOTE: No other MicroPort Orthopedics Inc. products are involved in this recall. If product(s) is(are) located, please return immediately to the MicroPort Orthopedics Inc. Distribution Center at: 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with RECALL on several sides for better identification and processing. Should you have a question regarding returns, please contact MPOs Customer Experience Department available Monday through Friday 7:30 am to 7:30 pm CST, at 1-866-872-0211. Please complete and return the enclosed form immediately even if you do not have any affected product to return. This information is essential in order to carry out effectiveness checks required per FDA guidelines. Return the completed form by fax to: 901-867-4771, or by e-mail to: PostMarket@ortho.microport.com. Please feel free to 901-867-4771 should you have any questions.
- Root cause
- Labeling Change Control
- Status
- Open, Classified
- Product code
- LWJ
- Quantity affected
- 12,348 units
- Distribution
- Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT, NC, NH, NJ, NV, OH, PA, TN, TX, UT, VA, WA, WI including PR; and countries of: Bra
- Date initiated
- 2020-07-31
- Date posted
- 2020-09-09
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROFEMUR HIP SYSTEM MODULAR NECKS (K100866) | Wrightmedicaltechnologyinc | 2010-04-28 |
| PROFEMUR HIP SYSTEM MODULAR NECKS (K091423) | Wrightmedicaltechnologyinc | 2009-08-25 |
| PRO-FEMUR R (K003016) | Wrightmedicaltechnologyinc | 2000-12-13 |