Recall Z-0939-2018— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-01-03, terminated 2019-04-11. It names one FDA 510(k) clearance: K051491. Product: Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681). Reason: Two lots of hip implants are mislabeled..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-01-03
- Terminated
- 2019-04-11
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)
Reason for recall
Two lots of hip implants are mislabeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.