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U.S. Department of Health and Human Services

Class 2 Device Recall U2 Acetabular cup

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  Class 2 Device Recall U2 Acetabular cup see related information
Date Initiated by Firm February 20, 2013
Date Posted May 24, 2013
Recall Status1 Terminated 3 on March 26, 2014
Recall Number Z-1381-2013
Recall Event ID 64588
510(K)Number K121777  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product U2 Acetabular cup, Ti beads porous coated, ¿44mm
U2 Acetabular cup, Ti beads porous coated, ¿46mm
U2 Acetabular cup, Ti beads porous coated, ¿48mm
U2 Acetabular cup, Ti beads porous coated, ¿50mm
U2 Acetabular cup, Ti beads porous coated, ¿52mm
U2 Acetabular cup, Ti beads porous coated, ¿54mm
U2 Acetabular cup, Ti beads porous coated, ¿56mm
U2 Acetabular cup, Ti beads porous coated, ¿58mm
U2 Acetabular cup, Ti beads porous coated, ¿60mm
U2 Acetabular cup, Ti beads porous coated, ¿62mm
U2 Acetabular cup liner assembly, 10¿hooded,44mm
U2 Acetabular cup liner assembly, 10¿hooded,46mm
U2 Acetabular cup liner assembly, 10¿hooded,48mm
U2 Acetabular cup liner assembly, 10¿hooded,50mm
U2 Acetabular cup liner assembly, 10¿hooded,52mm
U2 Acetabular cup liner assembly, 10¿hooded,54mm
U2 Acetabular cup liner assembly, 10¿hooded,56mm
U2 Acetabular cup liner assembly, 10¿hooded,58mm
U2 Acetabular cup liner assembly, 10¿hooded,60mm
U2 Acetabular cup liner assembly, 10¿hooded,62mm

Variety of hip and knee implants and instruments, multiple uses.

Code Information Item No. 1303-5444 1303-5446 1303-5448 1303-5450 1303-5452 1303-5454 1303-5456 1303-5458 1303-5460 1303-5462 1403-1044 1403-1046 1403-1048 1403-1250 1403-1252 1403-1654 1403-1656 1403-1658 1403-1660 1403-1662 
Recalling Firm/
Manufacturer		 Orthopedic Alliance LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
909-304-9001
Manufacturer Reason
for Recall		 The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
FDA Determined
Cause 2		 Labeling design
Action A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in Commerce 30 units
Distribution Nationwide Distribution including the states of CA, MD, TX, NV, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = UNITED ORTHOPEDIC CORP.
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