Z-0323-2016Class II

2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies...

Name: Z-0323-2016 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies...
Creator: Synthes (USA) Products LLC
Published: 2015-11-02
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-11-02 / Terminated / root cause: manufacturing process

FDA source

Synthes (USA) Products LLC began a recall of 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones... on 2015-11-02. FDA classified it as Class II and gives the reason as "It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615...". 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-0323-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-02
Posted: 2015-11-20
Terminated: 2016-07-15
Recalling firm: Synthes (USA) Products LLC
Product: 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Product code: HWC Screw, Fixation, Bone
Reason for recall: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Synthes sent an "URGENT FIELD SAFETY NOTIFICATION" letter dated November 2, 2015. Customers were asked to take the following actions: -Review the correct package insert (GP2615, attached). -If found, discard incorrect package insert associated with the locking screw noted in the table above. -Forward this Field Safety Notification to anyone in your facility that needs to be informed. -If the package insert has been forwarded to another facility, contact that facility. -Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. ---Send a copy of the completed Verification Section by: -Fax: 877-907-7514 or Scan/email: [email protected] -If the Verification Form is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page three (3) of this notification. -Maintain a copy of this Notification.
Quantity in commerce: 229
Distribution: Distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, , IN, MI, NJ, VT, ID, KS, MN, and MD, and the country of Canada.
Product codes and lots: Part Number Lot Number Product Description 212.818 7856527 Synthes 2.4mm Locking Screw SLF-TPNG with Stardrive Recess 18mm

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0323-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0323-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-20

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 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)