Z-2054-2012Class II

Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785...

Name: Z-2054-2012 Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785...
Creator: Synthes (USA) Products LLC
Published: 2012-05-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2012-05-31 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for... on 2012-05-31. FDA classified it as Class II and gives the reason as "USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2054-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-31
Posted: 2012-07-20
Terminated: 2015-08-31
Recalling firm: Synthes (USA) Products LLC
Product: Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature patients with the exception of the small stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of these indications: degenerative disc disease, spondylolisthesis, trauma, deformities or curvatures, tumor, stenosis and failed previous fusion.
Product code: MNI Orthosis, Spinal Pedicle Fixation
Reason for recall: USS Lamina Hooks, Medium, Right are being recalled because the hooks are etched with the wrong part number - 498.321 (Lamina Hook, Medium, Left). The Lamina Hooks should be etched with part number 498.320 (Lamina Hook, Medium, right).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: SYNTHES sent a Medical Device Recall letter dated May 31, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. The letter requested consignees and sales reps remove recalled product from their inventory, call the firm at 1-800-479-6329 to receive an authorization number and complete the enclosed verification form and return to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, Colorado 80132. If customers do not have any of the affected product they were instructed to complete the Verification Section at the end of the letter by checking the appropirate box indicating that no affected porudct has been located. Return the document to Synthes by fax to 610-251-9005 or Scan/Email: [email protected]. For any questions please call 610-719-5450.
Quantity in commerce: 12 units
Distribution: Nationwide Distribution including GA, PA, SC, TX, and UT and Canada.
Product codes and lots: Catalog number 498.321, lot/serial #6876785

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2054-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2054-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-01	2012-07-20

Product code MNI

K020517Class IISynthes Dual-Opening UssSynthes (Usa) / cleared 2002-04-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)