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U.S. Department of Health and Human Services

Class 2 Device Recall Oblique Posterior Atraumatic Lumbar (OPAL) System

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  Class 2 Device Recall Oblique Posterior Atraumatic Lumbar (OPAL) System see related information
Date Initiated by Firm February 18, 2016
Create Date April 14, 2016
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-1392-2016
Recall Event ID 73552
510(K)Number K072791  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve

Product Usage - The OPAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the OPAL Spacer should be packed with autogenous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months or non-operative treatment. The OPAL Spacer is intended to be used with Synthes supplemental fixation, e.g. TSLP, ATB, Antegra, Pangea, USS Including ClickX) and small stature USS.
Code Information Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve
Recalling Firm/
Manufacturer		 Synthes (USA) Products LLC
1301 Goshen Pkwy
West Chester PA 19380-5986
For Additional Information Contact David Carvin
610-719-6500
Manufacturer Reason
for Recall		 The label on the outer packaging does not match the product inside and intended use of the device.
FDA Determined
Cause 2		 Labeling mix-ups
Action DePuy Synthes sent an Urgent Notice letter dated February 18, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from their stock and complete the attached Verification Section. For questions call 610-719-5450 or contact your DePuy Synthes Sales Consultant
Quantity in Commerce 6 units
Distribution Distributed in the US: OH and ND
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 = MAX and Original Applicant = SYNTHES SPINE
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