ClearanceBrief
Recall Z-0627-2021 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Biomet, Inc.

RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Po

DateDec 17, 2020 (initiated Nov 25, 2020)
StatusTerminated
ReasonSpecific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
Root causeProcess control
ActionOn November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked to do the following: Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has be
Quantity7428
DistributionWorldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K063570BIOMET TIBIAL LOCKING NAIL SYSTEM
Biomet Manufacturing Corp, Feb 27, 2007
K082446BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
Biomet, Inc., Oct 15, 2008
K912245AGC REVISION KNEE PROTHESIS
Biomet, Inc., Aug 19, 1991
K971890RECOVERY PROTRUSIO CAGE
Biomet, Inc., Aug 7, 1997
K990032MODULAR PROTUSIO CUP
Biomet, Inc., Feb 18, 1999