Z-1392-2016Class II

Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10...

Name: Z-1392-2016 Oblique Posterior Atraumatic Lumbar (OPAL) System, Polymeric spinal fusion cage, non-sterile, OPAL Spacer 10...
Creator: Synthes (USA) Products LLC
Published: 2016-02-18
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2016-02-18 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of 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 -... on 2016-02-18. FDA classified it as Class II and gives the reason as "The label on the outer packaging does not match the product inside and intended use of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1392-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-04-14
Terminated: 2016-11-08
Recalling firm: Synthes (USA) Products LLC
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: The label on the outer packaging does not match the product inside and intended use of the device.
Root cause tag: labeling and UDI
FDA root cause: 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
Product codes and lots: Lot # 9984134, Catalog ID 08.803.051, OPAL Spacer 10 mm x 24 mm, 11 mm Height - Revolve

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1392-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1392-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-20	2016-04-14

Product code MAX

K072791Class IIOracle Spacer, Opal SpacerSynthes Spine / cleared 2007-12-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)