Z-0380-2014Class II

2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies...

Name: Z-0380-2014 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-31 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones... on 2013-07-31. FDA classified it as Class II and gives the reason as "Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw". 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-0380-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-11-22
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
Product: 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Synthes sent an URGENT NOTICE: MEDICAL DEVICE RECALL letter dated July 31, 2013, to all affected customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Nuber, complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located, also indicate the number of devices found and note the Return Authorization Number. Fax the documents to Synthes at 1-866-792-6446 or email to [email protected]. Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.
Quantity in commerce: 98
Distribution: Nationwide Distribution including PA, CA, FL, MO, KS, IN, IL, WV, KY, LA, NM, SC, IA, TX, AZ, GA, NC, OK, NY, TN, MI, CO, and MT.
Product codes and lots: Lot 3420620

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0380-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0380-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code HRS

K063049Class IISynthes (USA) Modular Mini Fragment Lcp SystemSynthes (Usa) / cleared 2006-12-18

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)